[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FGA":3},{"classification":4,"mappedDevices":84,"similarCandidates":85,"relatedClassifications":158,"syncDates":578},{"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":77,"updated_at":78,"recall_count":79,"latest_recall_date":80,"k510_count":81,"pma_count":82,"event_count":83},620,"FGA","Kit, Nephroscope","2","876.1500","GU","Gastroenterology, Urology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":75,"product_code":6,"review_panel":10,"gmp_exempt_flag":75,"third_party_flag":75,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":75,"medical_specialty_description":11,"summary_malfunction_reporting":76},{"k_number":17,"fei_number":28,"registration_number":63},[18,19,20,21,22,23,24,25,26,27],"K922826","K072594","K232370","K950433","K940594","K770729","K994223","K791182","K853486","K151308",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62],"1820334","3023460764","3014893827","3002807798","3002808088","3007475226","3004361445","3006546082","3014447948","3006149253","3010400865","1000343527","3014279513","3002808001","3011986317","3023102955","2020550","3013031133","1221826","1825146","1418479","3011050570","3013247477","3008386005","3025482817","4430","3013497507","3000219468","3000206435","3010707607","3014342096","3002808268","3010419931","3002808273",[29,64,65,30,66,31,67,68,35,36,39,40,41,69,43,70,71,44,45,46,47,48,72,49,50,51,52,53,55,73,74,58,59,61],"9610773","9614434","2030624","3014644276","3010202439","3017425975","8043903","8010349","8010487","9611102","9610617","N","Ineligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",8,"2024-10-02",10,0,95,[],[86,94,101,108,115,122,129,136,144,151],{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":82,"vector_similarity":92,"score":93},1719,"硬性腎盂鏡","Ⅱ","15290000",0.545455,0.718845,0.0320184,{"medical_device_id":95,"generic_name":96,"class_classification":89,"jmdn_code":97,"name_similarity":98,"definition_similarity":82,"vector_similarity":99,"score":100},1692,"ビデオ軟性腎盂鏡","38663000",0.387097,0.72484,0.032002,{"medical_device_id":102,"generic_name":103,"class_classification":89,"jmdn_code":104,"name_similarity":105,"definition_similarity":82,"vector_similarity":106,"score":107},1654,"軟性腎盂鏡","35502000",0.48,0.715661,0.0315136,{"medical_device_id":109,"generic_name":110,"class_classification":89,"jmdn_code":111,"name_similarity":112,"definition_similarity":82,"vector_similarity":113,"score":114},1721,"腎盂鏡検査キット","32083000",0.291667,0.724503,0.0310245,{"medical_device_id":116,"generic_name":117,"class_classification":89,"jmdn_code":118,"name_similarity":119,"definition_similarity":82,"vector_similarity":120,"score":121},1736,"腹腔鏡キット","32043000",0.333333,0.67141,0.0301178,{"medical_device_id":123,"generic_name":124,"class_classification":89,"jmdn_code":125,"name_similarity":126,"definition_similarity":82,"vector_similarity":127,"score":128},2910,"隅角鏡","11894000",0.227273,0.660097,0.026334,{"medical_device_id":130,"generic_name":131,"class_classification":89,"jmdn_code":132,"name_similarity":133,"definition_similarity":82,"vector_similarity":134,"score":135},1869,"腎臓生検キット","16834000",0.137931,0.742391,0.0163934,{"medical_device_id":137,"generic_name":138,"class_classification":139,"jmdn_code":140,"name_similarity":141,"definition_similarity":82,"vector_similarity":142,"score":143},21,"硬性神経内視鏡","Ⅳ","36904000",0.32,0.585418,0.0153846,{"medical_device_id":145,"generic_name":146,"class_classification":89,"jmdn_code":147,"name_similarity":148,"definition_similarity":82,"vector_similarity":149,"score":150},1988,"泌尿器用カテーテルイントロデューサキット","32030000",0.0930233,0.696859,0.0151515,{"medical_device_id":152,"generic_name":153,"class_classification":139,"jmdn_code":154,"name_similarity":155,"definition_similarity":82,"vector_similarity":156,"score":157},9,"軟性神経内視鏡","37181000",0.285714,0.580578,0.0149254,[159,163,167,171,175,179,183,187,191,195,199,203,207,211,215,219,223,227,230,234,237,241,245,249,253,257,260,264,268,272,275,279,282,286,289,292,296,300,303,306,310,314,318,322,325,329,332,335,338,341,344,347,350,353,356,360,364,367,370,374,377,380,384,387,390,393,396,399,403,406,409,412,415,418,421,424,428,431,434,437,440,443,446,449,452,455,458,461,464,467,470,474,477,480,483,486,489,492,495,498,501,503,506,509,512,515,518,521,524,527,530,533,536,539,542,545,548,551,554,557,560,563,566,569,572,575],{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":184,"device_name":185,"device_class":8,"k510_count":186},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":192,"device_name":193,"device_class":8,"k510_count":194},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":200,"device_name":201,"device_class":8,"k510_count":202},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":204,"device_name":205,"device_class":8,"k510_count":206},"ODC","Endoscope Channel Accessory",72,{"product_code":208,"device_name":209,"device_class":8,"k510_count":210},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":212,"device_name":213,"device_class":8,"k510_count":214},"OWN","Confocal Optical Imaging",62,{"product_code":216,"device_name":217,"device_class":8,"k510_count":218},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":220,"device_name":221,"device_class":8,"k510_count":222},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":224,"device_name":225,"device_class":8,"k510_count":226},"FDX","Endoscopic Cytology Brush",44,{"product_code":228,"device_name":229,"device_class":8,"k510_count":226},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":231,"device_name":232,"device_class":8,"k510_count":233},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":235,"device_name":236,"device_class":8,"k510_count":233},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":238,"device_name":239,"device_class":8,"k510_count":240},"LYK","Angioscope",41,{"product_code":242,"device_name":243,"device_class":8,"k510_count":244},"MPA","Endoilluminator",40,{"product_code":246,"device_name":247,"device_class":8,"k510_count":248},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":250,"device_name":251,"device_class":8,"k510_count":252},"FCW","Light Source, Fiberoptic, Routine",31,{"product_code":254,"device_name":255,"device_class":8,"k510_count":256},"FER","Anoscope And Accessories",27,{"product_code":258,"device_name":259,"device_class":8,"k510_count":256},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":261,"device_name":262,"device_class":8,"k510_count":263},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":265,"device_name":266,"device_class":8,"k510_count":267},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":269,"device_name":270,"device_class":8,"k510_count":271},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":273,"device_name":274,"device_class":8,"k510_count":271},"FJL","Resectoscope",{"product_code":276,"device_name":277,"device_class":8,"k510_count":278},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":280,"device_name":281,"device_class":8,"k510_count":137},"FEQ","Pump, Air, Non-Manual, For Endoscope",{"product_code":283,"device_name":284,"device_class":12,"k510_count":285},"FCO","Box, Battery, Rechargeable",20,{"product_code":287,"device_name":288,"device_class":8,"k510_count":285},"FDA","Enteroscope And Accessories",{"product_code":290,"device_name":291,"device_class":8,"k510_count":285},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":293,"device_name":294,"device_class":8,"k510_count":295},"FBO","Cystourethroscope",19,{"product_code":297,"device_name":298,"device_class":8,"k510_count":299},"GCM","Endoscope, Rigid",18,{"product_code":301,"device_name":302,"device_class":8,"k510_count":299},"ODA","Endoscopic Central Control Unit",{"product_code":304,"device_name":305,"device_class":8,"k510_count":299},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":307,"device_name":308,"device_class":8,"k510_count":309},"FHO","Pneumoperitoneum Needle",15,{"product_code":311,"device_name":312,"device_class":8,"k510_count":313},"GCI","Laryngoscope, Endoscope",14,{"product_code":315,"device_name":316,"device_class":8,"k510_count":317},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":319,"device_name":320,"device_class":8,"k510_count":321},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":323,"device_name":324,"device_class":8,"k510_count":321},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":326,"device_name":327,"device_class":8,"k510_count":328},"FDC","Resectoscope, Working Element",11,{"product_code":330,"device_name":331,"device_class":8,"k510_count":328},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":333,"device_name":334,"device_class":8,"k510_count":328},"OTJ","Laparoscopic Single Port Access Device",{"product_code":336,"device_name":337,"device_class":8,"k510_count":81},"OCV","Endoscope Holder",{"product_code":339,"device_name":340,"device_class":8,"k510_count":152},"GCS","Endoscope, Battery-Powered And Accessories",{"product_code":342,"device_name":343,"device_class":8,"k510_count":152},"NTN","Led Light Source",{"product_code":345,"device_name":346,"device_class":8,"k510_count":152},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":348,"device_name":349,"device_class":8,"k510_count":152},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":351,"device_name":352,"device_class":8,"k510_count":152},"PLL","Submucosal Injection Agent",{"product_code":354,"device_name":355,"device_class":8,"k510_count":79},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",{"product_code":357,"device_name":358,"device_class":8,"k510_count":359},"GDB","Endoscope, Fiber Optic",7,{"product_code":361,"device_name":362,"device_class":8,"k510_count":363},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",6,{"product_code":365,"device_name":366,"device_class":12,"k510_count":363},"MNK","Endoscopic Bite Block",{"product_code":368,"device_name":369,"device_class":8,"k510_count":363},"OCU","Endoscopic Storage Cover",{"product_code":371,"device_name":372,"device_class":8,"k510_count":373},"FBP","Telescope, Rigid, Endoscopic",5,{"product_code":375,"device_name":376,"device_class":8,"k510_count":373},"GCQ","Endoscope, Flexible",{"product_code":378,"device_name":379,"device_class":8,"k510_count":373},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":381,"device_name":382,"device_class":8,"k510_count":383},"FDE","Laparoscopy Kit",4,{"product_code":385,"device_name":386,"device_class":12,"k510_count":383},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":388,"device_name":389,"device_class":8,"k510_count":383},"FGS","Carrier, Sponge, Endoscopic",{"product_code":391,"device_name":392,"device_class":8,"k510_count":383},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":394,"device_name":395,"device_class":12,"k510_count":383},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":397,"device_name":398,"device_class":8,"k510_count":383},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":400,"device_name":401,"device_class":8,"k510_count":402},"FCC","Endoscopic Magnetic Retriever",3,{"product_code":404,"device_name":405,"device_class":8,"k510_count":402},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":407,"device_name":408,"device_class":12,"k510_count":402},"FCY","Bulb, Inflation, For Endoscope",{"product_code":410,"device_name":411,"device_class":8,"k510_count":402},"FEC","Obturator, For Endoscope",{"product_code":413,"device_name":414,"device_class":8,"k510_count":402},"FFZ","Cord, Electric, For Endoscope",{"product_code":416,"device_name":417,"device_class":8,"k510_count":402},"FGC","Urethroscope",{"product_code":419,"device_name":420,"device_class":8,"k510_count":402},"GCO","Endoscope, Mirror",{"product_code":422,"device_name":423,"device_class":8,"k510_count":402},"NWU","Endoscope Introducer Kit",{"product_code":425,"device_name":426,"device_class":8,"k510_count":427},"FAK","Panendoscope (Gastroduodenoscope)",2,{"product_code":429,"device_name":430,"device_class":8,"k510_count":427},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":432,"device_name":433,"device_class":12,"k510_count":427},"FCP","Box, Battery, Pocket",{"product_code":435,"device_name":436,"device_class":12,"k510_count":427},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":438,"device_name":439,"device_class":12,"k510_count":427},"FEA","Attachment, Teaching, For Endoscope",{"product_code":441,"device_name":442,"device_class":12,"k510_count":427},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":444,"device_name":445,"device_class":12,"k510_count":427},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":447,"device_name":448,"device_class":8,"k510_count":427},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":450,"device_name":451,"device_class":8,"k510_count":427},"FTI","Lamp, Endoscope, Incandescent",{"product_code":453,"device_name":454,"device_class":8,"k510_count":427},"GCF","Proctoscope",{"product_code":456,"device_name":457,"device_class":8,"k510_count":427},"KGD","Scissors For Cystoscope",{"product_code":459,"device_name":460,"device_class":8,"k510_count":427},"NBG","Marker, Colon",{"product_code":462,"device_name":463,"device_class":8,"k510_count":427},"NEQ","Device, Telemedicine, Robotic",{"product_code":465,"device_name":466,"device_class":8,"k510_count":427},"PCV","Endoscopic Leak Tester",{"product_code":468,"device_name":469,"device_class":8,"k510_count":427},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":471,"device_name":472,"device_class":8,"k510_count":473},"FAL","Panendoscope (Urethroscope)",1,{"product_code":475,"device_name":476,"device_class":8,"k510_count":473},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":478,"device_name":479,"device_class":8,"k510_count":473},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":481,"device_name":482,"device_class":12,"k510_count":473},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":484,"device_name":485,"device_class":8,"k510_count":473},"GCW","Transformer, Endoscope",{"product_code":487,"device_name":488,"device_class":8,"k510_count":473},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":490,"device_name":491,"device_class":8,"k510_count":473},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":493,"device_name":494,"device_class":8,"k510_count":473},"KYH","Endoscope, Ophthalmic",{"product_code":496,"device_name":497,"device_class":8,"k510_count":473},"MFJ","Device, Endoscopic Suturing",{"product_code":499,"device_name":500,"device_class":8,"k510_count":473},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":502,"device_name":181,"device_class":8,"k510_count":473},"OCS",{"product_code":504,"device_name":505,"device_class":8,"k510_count":473},"PGU","Spatial Imaging For Display Of Endoscope Position",{"product_code":507,"device_name":508,"device_class":8,"k510_count":473},"PUP","Endoscope Maintenance System",{"product_code":510,"device_name":511,"device_class":8,"k510_count":473},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":513,"device_name":514,"device_class":8,"k510_count":473},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":516,"device_name":517,"device_class":12,"k510_count":82},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":519,"device_name":520,"device_class":8,"k510_count":82},"FBI","Rongeur, Cystoscopic",{"product_code":522,"device_name":523,"device_class":12,"k510_count":82},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":525,"device_name":526,"device_class":8,"k510_count":82},"FDR","Sphyncteroscope",{"product_code":528,"device_name":529,"device_class":8,"k510_count":82},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":531,"device_name":532,"device_class":12,"k510_count":82},"FDY","Device, Measuring, For Panendoscope",{"product_code":534,"device_name":535,"device_class":8,"k510_count":82},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":537,"device_name":538,"device_class":8,"k510_count":82},"GCG","Peritoneoscope",{"product_code":540,"device_name":541,"device_class":8,"k510_count":82},"GCH","Mediastinoscope, Diagnostic",{"product_code":543,"device_name":544,"device_class":8,"k510_count":82},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":546,"device_name":547,"device_class":8,"k510_count":82},"GCN","Endoscope, Prism",{"product_code":549,"device_name":550,"device_class":8,"k510_count":82},"NKZ","Endoilluminator, Reprocessed",{"product_code":552,"device_name":553,"device_class":8,"k510_count":82},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":555,"device_name":556,"device_class":8,"k510_count":82},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":558,"device_name":559,"device_class":8,"k510_count":82},"NWT","Endoscopic Cholangiogram Kit",{"product_code":561,"device_name":562,"device_class":12,"k510_count":82},"PHT","Basin For Endoscope Reprocessing",{"product_code":564,"device_name":565,"device_class":8,"k510_count":82},"PPE","Nephroscope Set",{"product_code":567,"device_name":568,"device_class":8,"k510_count":82},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":570,"device_name":571,"device_class":8,"k510_count":82},"PTR","Scissors For Cytoscope, Exempt",{"product_code":573,"device_name":574,"device_class":8,"k510_count":82},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":576,"device_name":577,"device_class":8,"k510_count":82},"SBX","Software For Endoscopy Procedure Metrics",{"510k":579,"classification":580,"enforcement":581,"event":582,"pma":583,"warning_letter":584},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]