[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NBG":3},{"classification":4,"mappedDevices":42,"similarCandidates":43,"relatedClassifications":115,"syncDates":538,"translation":545,"marketSummary":551,"recalls":568,"k510s":570,"pmas":583},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":36,"updated_at":37,"recall_count":38,"latest_recall_date":39,"k510_count":40,"pma_count":38,"event_count":41},324,"NBG","Marker, Colon","2","876.1500","GU","Gastroenterology, Urology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":34,"product_code":6,"review_panel":10,"gmp_exempt_flag":34,"third_party_flag":34,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":34,"medical_specialty_description":11,"summary_malfunction_reporting":35},{"k_number":17,"fei_number":20,"registration_number":30},[18,19],"K042901","K993951",[21,22,23,24,25,26,27,28,29],"3004837686","1000122656","3005248192","2182979","3013337852","3013734919","3013440400","1000121355","1000221028",[31,21,32,33,23,24,25,26,27],"1528319","3014718111","2132588","N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:48.493322+00:00",0,null,2,5,[],[44,52,60,68,75,82,88,94,101,108],{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":38,"vector_similarity":50,"score":51},4167,"歯科用マーカ","Ⅰ","70925000",0.35,0.682314,0.0325225,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":38,"vector_similarity":58,"score":59},688,"植込み型病変識別マーカ","Ⅲ","40808000",0.186047,0.684561,0.0322665,{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":38,"vector_similarity":66,"score":67},1649,"軟性大腸鏡","Ⅱ","34966000",0.172414,0.648092,0.0298507,{"medical_device_id":69,"generic_name":70,"class_classification":63,"jmdn_code":71,"name_similarity":72,"definition_similarity":38,"vector_similarity":73,"score":74},1687,"ビデオ軟性大腸鏡","36117000",0.142857,0.652625,0.0278201,{"medical_device_id":76,"generic_name":77,"class_classification":47,"jmdn_code":78,"name_similarity":79,"definition_similarity":38,"vector_similarity":80,"score":81},3848,"大腸灌流装置","43827000",0.181818,0.589023,0.0273897,{"medical_device_id":83,"generic_name":84,"class_classification":63,"jmdn_code":85,"name_similarity":72,"definition_similarity":38,"vector_similarity":86,"score":87},2320,"胃・結腸洗浄ユニット","35994000",0.599505,0.0255036,{"medical_device_id":89,"generic_name":90,"class_classification":47,"jmdn_code":91,"name_similarity":72,"definition_similarity":38,"vector_similarity":92,"score":93},3428,"コルポスコープ","10960000",0.590191,0.024563,{"medical_device_id":95,"generic_name":96,"class_classification":63,"jmdn_code":97,"name_similarity":98,"definition_similarity":38,"vector_similarity":99,"score":100},1858,"マーカ挿入用セット","70207000",0.307692,0.581731,0.016129,{"medical_device_id":102,"generic_name":103,"class_classification":47,"jmdn_code":104,"name_similarity":105,"definition_similarity":38,"vector_similarity":106,"score":107},3450,"再使用可能な内視鏡用細胞診ブラシ","38833000",0.0434783,0.660742,0.015873,{"medical_device_id":109,"generic_name":110,"class_classification":63,"jmdn_code":111,"name_similarity":112,"definition_similarity":38,"vector_similarity":113,"score":114},2824,"歯科用色調遮蔽材料","70919000",0.176471,0.472655,0.0153846,[116,120,124,128,132,136,140,144,148,152,156,160,164,168,172,176,180,184,187,191,194,198,202,206,210,214,217,221,225,229,232,236,240,245,248,251,255,259,262,265,269,273,277,281,284,288,291,294,298,301,305,308,311,314,317,321,325,329,332,335,338,341,344,348,351,354,357,360,363,367,370,373,376,379,382,385,388,391,394,397,400,403,406,409,412,415,418,421,424,427,430,434,437,440,443,446,449,452,455,458,461,463,466,469,472,475,478,481,484,487,490,493,496,499,502,505,508,511,514,517,520,523,526,529,532,535],{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"ODC","Endoscope Channel Accessory",72,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"OWN","Confocal Optical Imaging",62,{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"FDX","Endoscopic Cytology Brush",44,{"product_code":185,"device_name":186,"device_class":8,"k510_count":183},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":192,"device_name":193,"device_class":8,"k510_count":190},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":195,"device_name":196,"device_class":8,"k510_count":197},"LYK","Angioscope",41,{"product_code":199,"device_name":200,"device_class":8,"k510_count":201},"MPA","Endoilluminator",40,{"product_code":203,"device_name":204,"device_class":8,"k510_count":205},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":207,"device_name":208,"device_class":8,"k510_count":209},"FCW","Light Source, Fiberoptic, Routine",31,{"product_code":211,"device_name":212,"device_class":8,"k510_count":213},"FER","Anoscope And Accessories",27,{"product_code":215,"device_name":216,"device_class":8,"k510_count":213},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":230,"device_name":231,"device_class":8,"k510_count":228},"FJL","Resectoscope",{"product_code":233,"device_name":234,"device_class":8,"k510_count":235},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":237,"device_name":238,"device_class":8,"k510_count":239},"FEQ","Pump, Air, Non-Manual, For Endoscope",21,{"product_code":241,"device_name":242,"device_class":243,"k510_count":244},"FCO","Box, Battery, Rechargeable","1",20,{"product_code":246,"device_name":247,"device_class":8,"k510_count":244},"FDA","Enteroscope And Accessories",{"product_code":249,"device_name":250,"device_class":8,"k510_count":244},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":252,"device_name":253,"device_class":8,"k510_count":254},"FBO","Cystourethroscope",19,{"product_code":256,"device_name":257,"device_class":8,"k510_count":258},"GCM","Endoscope, Rigid",18,{"product_code":260,"device_name":261,"device_class":8,"k510_count":258},"ODA","Endoscopic Central Control Unit",{"product_code":263,"device_name":264,"device_class":8,"k510_count":258},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":266,"device_name":267,"device_class":8,"k510_count":268},"FHO","Pneumoperitoneum Needle",15,{"product_code":270,"device_name":271,"device_class":8,"k510_count":272},"GCI","Laryngoscope, Endoscope",14,{"product_code":274,"device_name":275,"device_class":8,"k510_count":276},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":278,"device_name":279,"device_class":8,"k510_count":280},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":282,"device_name":283,"device_class":8,"k510_count":280},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":285,"device_name":286,"device_class":8,"k510_count":287},"FDC","Resectoscope, Working Element",11,{"product_code":289,"device_name":290,"device_class":8,"k510_count":287},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":292,"device_name":293,"device_class":8,"k510_count":287},"OTJ","Laparoscopic Single Port Access Device",{"product_code":295,"device_name":296,"device_class":8,"k510_count":297},"FGA","Kit, Nephroscope",10,{"product_code":299,"device_name":300,"device_class":8,"k510_count":297},"OCV","Endoscope Holder",{"product_code":302,"device_name":303,"device_class":8,"k510_count":304},"GCS","Endoscope, Battery-Powered And Accessories",9,{"product_code":306,"device_name":307,"device_class":8,"k510_count":304},"NTN","Led Light Source",{"product_code":309,"device_name":310,"device_class":8,"k510_count":304},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":312,"device_name":313,"device_class":8,"k510_count":304},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":315,"device_name":316,"device_class":8,"k510_count":304},"PLL","Submucosal Injection Agent",{"product_code":318,"device_name":319,"device_class":8,"k510_count":320},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",8,{"product_code":322,"device_name":323,"device_class":8,"k510_count":324},"GDB","Endoscope, Fiber Optic",7,{"product_code":326,"device_name":327,"device_class":8,"k510_count":328},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",6,{"product_code":330,"device_name":331,"device_class":243,"k510_count":328},"MNK","Endoscopic Bite Block",{"product_code":333,"device_name":334,"device_class":8,"k510_count":328},"OCU","Endoscopic Storage Cover",{"product_code":336,"device_name":337,"device_class":8,"k510_count":41},"FBP","Telescope, Rigid, Endoscopic",{"product_code":339,"device_name":340,"device_class":8,"k510_count":41},"GCQ","Endoscope, Flexible",{"product_code":342,"device_name":343,"device_class":8,"k510_count":41},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":345,"device_name":346,"device_class":8,"k510_count":347},"FDE","Laparoscopy Kit",4,{"product_code":349,"device_name":350,"device_class":243,"k510_count":347},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":352,"device_name":353,"device_class":8,"k510_count":347},"FGS","Carrier, Sponge, Endoscopic",{"product_code":355,"device_name":356,"device_class":8,"k510_count":347},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":358,"device_name":359,"device_class":243,"k510_count":347},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":361,"device_name":362,"device_class":8,"k510_count":347},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":364,"device_name":365,"device_class":8,"k510_count":366},"FCC","Endoscopic Magnetic Retriever",3,{"product_code":368,"device_name":369,"device_class":8,"k510_count":366},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":371,"device_name":372,"device_class":243,"k510_count":366},"FCY","Bulb, Inflation, For Endoscope",{"product_code":374,"device_name":375,"device_class":8,"k510_count":366},"FEC","Obturator, For Endoscope",{"product_code":377,"device_name":378,"device_class":8,"k510_count":366},"FFZ","Cord, Electric, For Endoscope",{"product_code":380,"device_name":381,"device_class":8,"k510_count":366},"FGC","Urethroscope",{"product_code":383,"device_name":384,"device_class":8,"k510_count":366},"GCO","Endoscope, Mirror",{"product_code":386,"device_name":387,"device_class":8,"k510_count":366},"NWU","Endoscope Introducer Kit",{"product_code":389,"device_name":390,"device_class":8,"k510_count":40},"FAK","Panendoscope (Gastroduodenoscope)",{"product_code":392,"device_name":393,"device_class":8,"k510_count":40},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":395,"device_name":396,"device_class":243,"k510_count":40},"FCP","Box, Battery, Pocket",{"product_code":398,"device_name":399,"device_class":243,"k510_count":40},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":401,"device_name":402,"device_class":243,"k510_count":40},"FEA","Attachment, Teaching, For Endoscope",{"product_code":404,"device_name":405,"device_class":243,"k510_count":40},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":407,"device_name":408,"device_class":243,"k510_count":40},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":410,"device_name":411,"device_class":8,"k510_count":40},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":413,"device_name":414,"device_class":8,"k510_count":40},"FTI","Lamp, Endoscope, Incandescent",{"product_code":416,"device_name":417,"device_class":8,"k510_count":40},"GCF","Proctoscope",{"product_code":419,"device_name":420,"device_class":8,"k510_count":40},"KGD","Scissors For Cystoscope",{"product_code":422,"device_name":423,"device_class":8,"k510_count":40},"NEQ","Device, Telemedicine, Robotic",{"product_code":425,"device_name":426,"device_class":8,"k510_count":40},"PCV","Endoscopic Leak Tester",{"product_code":428,"device_name":429,"device_class":8,"k510_count":40},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":431,"device_name":432,"device_class":8,"k510_count":433},"FAL","Panendoscope (Urethroscope)",1,{"product_code":435,"device_name":436,"device_class":8,"k510_count":433},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":438,"device_name":439,"device_class":8,"k510_count":433},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":441,"device_name":442,"device_class":243,"k510_count":433},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":444,"device_name":445,"device_class":8,"k510_count":433},"GCW","Transformer, Endoscope",{"product_code":447,"device_name":448,"device_class":8,"k510_count":433},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":450,"device_name":451,"device_class":8,"k510_count":433},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":453,"device_name":454,"device_class":8,"k510_count":433},"KYH","Endoscope, Ophthalmic",{"product_code":456,"device_name":457,"device_class":8,"k510_count":433},"MFJ","Device, Endoscopic Suturing",{"product_code":459,"device_name":460,"device_class":8,"k510_count":433},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":462,"device_name":138,"device_class":8,"k510_count":433},"OCS",{"product_code":464,"device_name":465,"device_class":8,"k510_count":433},"PGU","Spatial Imaging For Display Of Endoscope Position",{"product_code":467,"device_name":468,"device_class":8,"k510_count":433},"PUP","Endoscope Maintenance System",{"product_code":470,"device_name":471,"device_class":8,"k510_count":433},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":473,"device_name":474,"device_class":8,"k510_count":433},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":476,"device_name":477,"device_class":243,"k510_count":38},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":479,"device_name":480,"device_class":8,"k510_count":38},"FBI","Rongeur, Cystoscopic",{"product_code":482,"device_name":483,"device_class":243,"k510_count":38},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":485,"device_name":486,"device_class":8,"k510_count":38},"FDR","Sphyncteroscope",{"product_code":488,"device_name":489,"device_class":8,"k510_count":38},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":491,"device_name":492,"device_class":243,"k510_count":38},"FDY","Device, Measuring, For Panendoscope",{"product_code":494,"device_name":495,"device_class":8,"k510_count":38},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":497,"device_name":498,"device_class":8,"k510_count":38},"GCG","Peritoneoscope",{"product_code":500,"device_name":501,"device_class":8,"k510_count":38},"GCH","Mediastinoscope, Diagnostic",{"product_code":503,"device_name":504,"device_class":8,"k510_count":38},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":506,"device_name":507,"device_class":8,"k510_count":38},"GCN","Endoscope, Prism",{"product_code":509,"device_name":510,"device_class":8,"k510_count":38},"NKZ","Endoilluminator, Reprocessed",{"product_code":512,"device_name":513,"device_class":8,"k510_count":38},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":515,"device_name":516,"device_class":8,"k510_count":38},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":518,"device_name":519,"device_class":8,"k510_count":38},"NWT","Endoscopic Cholangiogram Kit",{"product_code":521,"device_name":522,"device_class":243,"k510_count":38},"PHT","Basin For Endoscope Reprocessing",{"product_code":524,"device_name":525,"device_class":8,"k510_count":38},"PPE","Nephroscope Set",{"product_code":527,"device_name":528,"device_class":8,"k510_count":38},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":530,"device_name":531,"device_class":8,"k510_count":38},"PTR","Scissors For Cytoscope, Exempt",{"product_code":533,"device_name":534,"device_class":8,"k510_count":38},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":536,"device_name":537,"device_class":8,"k510_count":38},"SBX","Software For Endoscopy Procedure Metrics",{"510k":539,"classification":540,"enforcement":541,"event":542,"pma":543,"warning_letter":544},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":546,"definition_ja":39,"commentary_ja":547,"model_name":548,"source_hash":549,"reviewed_by":39,"reviewed_at":39,"created_at":550,"updated_at":550},"大腸マーカー","本品は米国のFDA分類においてクラスIIに区分される医療機器です。クラスIIの機器は通常510(k)による市販前届出の対象となりますが、本品はその中でも届出が免除される品目に該当します。","claude-sonnet-5","67162ba616b3d876e2f7f550be9da9c3467875b1e63fbb71e3d97fc4c479ae5f","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":552,"stats":553,"stats_hash":566,"model_name":548,"created_at":567,"updated_at":567},"本製品コードでは、510(k)の累計届出件数は2件で、参入企業数は2社となっており、直近5年間の届出はありません。不具合報告は累計5件で、いずれも不具合（Malfunction）に分類されており、死亡・傷害の報告は確認されていません。主な問題としてはConnection Problem（接続の問題）、Loose or Intermittent Connection（接続の緩み・断続）、Leak\u002FSplash（漏れ・飛散）が挙げられています。回収については、累計件数・クラスI〜IIIともに確認されていません。",{"pma":554,"k510":555,"as_of":557,"events":558,"recalls":560,"top_problems":562},{"latest":39,"originals":38,"supplements":38},{"total":40,"last5y":38,"latest":556,"applicants":40},"2005-03-16","2026-08",{"death":38,"other":38,"total":41,"injury":38,"last5y":41,"malfunction":41,"latest_month":559},"2022-07",{"total":38,"last5y":38,"latest":39,"class_i":38,"class_ii":38,"class_iii":38,"top_root_causes":561},[],[563,564,565],"Connection Problem","Loose or Intermittent Connection","Leak\u002FSplash","c11c5f9d6751d7a3f4e7f77f08f3cc4b8599249ddaa04dd39438e1a95085a9e3","2026-08-24T04:57:04.90455+00:00",{"items":569,"total":38},[],{"items":571,"total":40},[572,578],{"k_number":18,"device_name":573,"applicant":574,"decision_date":556,"clearance_type":575,"decision_code":576,"statement_or_summary":577},"ENDOMARK STERILE INDIA INK","Pmt Corp.","Traditional","SESE","Summary",{"k_number":19,"device_name":579,"applicant":580,"decision_date":581,"clearance_type":575,"decision_code":576,"statement_or_summary":582},"SPOT ENDOSCOPIC MARKER","Chek-Med Systems","2000-02-18","Statement",{"items":584,"total":38},[]]