[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FCC":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":110,"syncDates":533,"translation":540,"marketSummary":547,"recalls":560,"k510s":562,"pmas":577},{"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":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":28,"pma_count":26,"event_count":26},5176,"FCC","Endoscopic Magnetic Retriever","2","876.1500","GU","Gastroenterology, Urology","1","to endoscopically retrieve magnetic foreign objects",false,{"openfda":16,"definition":13,"device_name":7,"review_code":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":22,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":23},{"k_number":17},[18,19,20],"K904668","K843135","K800971","","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:47.318533+00:00",0,null,3,[],[31,40,48,56,64,72,80,89,96,104],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":37,"vector_similarity":38,"score":39},3463,"内視鏡用メジャ","Ⅰ","32053000",0.266667,0.145833,0.631298,0.0283816,{"medical_device_id":41,"generic_name":42,"class_classification":34,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},3471,"内視鏡用シース","37086000",0.305556,0.142045,0.618775,0.0282982,{"medical_device_id":49,"generic_name":50,"class_classification":34,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},3444,"内視鏡用はさみ鉗子","35326001",0.244444,0.115556,0.641432,0.0271997,{"medical_device_id":57,"generic_name":58,"class_classification":34,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},3453,"内視鏡用非能動ナイフ","70166000",0.23913,0.128205,0.629783,0.0256034,{"medical_device_id":65,"generic_name":66,"class_classification":34,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},3450,"再使用可能な内視鏡用細胞診ブラシ","38833000",0.254902,0.137755,0.617142,0.0246521,{"medical_device_id":73,"generic_name":74,"class_classification":34,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},3823,"眼内異物除去用磁石","35495000",0.129032,0.296296,0.701847,0.0163934,{"medical_device_id":81,"generic_name":82,"class_classification":83,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},2910,"隅角鏡","Ⅱ","11894000",0.0810811,0.038961,0.662583,0.016129,{"medical_device_id":90,"generic_name":91,"class_classification":34,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":88},4286,"内視鏡用マウスピース","70951000",0.307692,0.119266,0.563983,{"medical_device_id":97,"generic_name":98,"class_classification":83,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},1788,"内視鏡挿入形状検出装置","70161000",0.150943,0.130252,0.64908,0.015873,{"medical_device_id":105,"generic_name":106,"class_classification":34,"jmdn_code":107,"name_similarity":44,"definition_similarity":108,"vector_similarity":109,"score":103},3630,"内視鏡用トロカール","37144000",0.10084,0.608002,[111,115,119,123,127,131,135,139,143,147,151,155,159,163,167,171,175,179,182,186,189,193,197,201,205,209,212,216,220,224,227,231,235,239,242,245,249,253,256,259,263,267,271,275,278,282,285,288,292,295,299,302,305,308,311,315,319,323,326,329,333,336,339,343,346,349,352,355,358,361,364,367,370,373,376,379,383,386,389,392,395,398,401,404,407,410,413,416,419,422,425,429,432,435,438,441,444,447,450,453,456,458,461,464,467,470,473,476,479,482,485,488,491,494,497,500,503,506,509,512,515,518,521,524,527,530],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"ODC","Endoscope Channel Accessory",72,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"OWN","Confocal Optical Imaging",62,{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"FDX","Endoscopic Cytology Brush",44,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":187,"device_name":188,"device_class":8,"k510_count":185},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":190,"device_name":191,"device_class":8,"k510_count":192},"LYK","Angioscope",41,{"product_code":194,"device_name":195,"device_class":8,"k510_count":196},"MPA","Endoilluminator",40,{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":202,"device_name":203,"device_class":8,"k510_count":204},"FCW","Light Source, Fiberoptic, Routine",31,{"product_code":206,"device_name":207,"device_class":8,"k510_count":208},"FER","Anoscope And Accessories",27,{"product_code":210,"device_name":211,"device_class":8,"k510_count":208},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":213,"device_name":214,"device_class":8,"k510_count":215},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":221,"device_name":222,"device_class":8,"k510_count":223},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":225,"device_name":226,"device_class":8,"k510_count":223},"FJL","Resectoscope",{"product_code":228,"device_name":229,"device_class":8,"k510_count":230},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":232,"device_name":233,"device_class":8,"k510_count":234},"FEQ","Pump, Air, Non-Manual, For Endoscope",21,{"product_code":236,"device_name":237,"device_class":12,"k510_count":238},"FCO","Box, Battery, Rechargeable",20,{"product_code":240,"device_name":241,"device_class":8,"k510_count":238},"FDA","Enteroscope And Accessories",{"product_code":243,"device_name":244,"device_class":8,"k510_count":238},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":246,"device_name":247,"device_class":8,"k510_count":248},"FBO","Cystourethroscope",19,{"product_code":250,"device_name":251,"device_class":8,"k510_count":252},"GCM","Endoscope, Rigid",18,{"product_code":254,"device_name":255,"device_class":8,"k510_count":252},"ODA","Endoscopic Central Control Unit",{"product_code":257,"device_name":258,"device_class":8,"k510_count":252},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":260,"device_name":261,"device_class":8,"k510_count":262},"FHO","Pneumoperitoneum Needle",15,{"product_code":264,"device_name":265,"device_class":8,"k510_count":266},"GCI","Laryngoscope, Endoscope",14,{"product_code":268,"device_name":269,"device_class":8,"k510_count":270},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":272,"device_name":273,"device_class":8,"k510_count":274},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":276,"device_name":277,"device_class":8,"k510_count":274},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":279,"device_name":280,"device_class":8,"k510_count":281},"FDC","Resectoscope, Working Element",11,{"product_code":283,"device_name":284,"device_class":8,"k510_count":281},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":286,"device_name":287,"device_class":8,"k510_count":281},"OTJ","Laparoscopic Single Port Access Device",{"product_code":289,"device_name":290,"device_class":8,"k510_count":291},"FGA","Kit, Nephroscope",10,{"product_code":293,"device_name":294,"device_class":8,"k510_count":291},"OCV","Endoscope Holder",{"product_code":296,"device_name":297,"device_class":8,"k510_count":298},"GCS","Endoscope, Battery-Powered And Accessories",9,{"product_code":300,"device_name":301,"device_class":8,"k510_count":298},"NTN","Led Light Source",{"product_code":303,"device_name":304,"device_class":8,"k510_count":298},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":306,"device_name":307,"device_class":8,"k510_count":298},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":309,"device_name":310,"device_class":8,"k510_count":298},"PLL","Submucosal Injection Agent",{"product_code":312,"device_name":313,"device_class":8,"k510_count":314},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",8,{"product_code":316,"device_name":317,"device_class":8,"k510_count":318},"GDB","Endoscope, Fiber Optic",7,{"product_code":320,"device_name":321,"device_class":8,"k510_count":322},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",6,{"product_code":324,"device_name":325,"device_class":12,"k510_count":322},"MNK","Endoscopic Bite Block",{"product_code":327,"device_name":328,"device_class":8,"k510_count":322},"OCU","Endoscopic Storage Cover",{"product_code":330,"device_name":331,"device_class":8,"k510_count":332},"FBP","Telescope, Rigid, Endoscopic",5,{"product_code":334,"device_name":335,"device_class":8,"k510_count":332},"GCQ","Endoscope, Flexible",{"product_code":337,"device_name":338,"device_class":8,"k510_count":332},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":340,"device_name":341,"device_class":8,"k510_count":342},"FDE","Laparoscopy Kit",4,{"product_code":344,"device_name":345,"device_class":12,"k510_count":342},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":347,"device_name":348,"device_class":8,"k510_count":342},"FGS","Carrier, Sponge, Endoscopic",{"product_code":350,"device_name":351,"device_class":8,"k510_count":342},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":353,"device_name":354,"device_class":12,"k510_count":342},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":356,"device_name":357,"device_class":8,"k510_count":342},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":359,"device_name":360,"device_class":8,"k510_count":28},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":362,"device_name":363,"device_class":12,"k510_count":28},"FCY","Bulb, Inflation, For Endoscope",{"product_code":365,"device_name":366,"device_class":8,"k510_count":28},"FEC","Obturator, For Endoscope",{"product_code":368,"device_name":369,"device_class":8,"k510_count":28},"FFZ","Cord, Electric, For Endoscope",{"product_code":371,"device_name":372,"device_class":8,"k510_count":28},"FGC","Urethroscope",{"product_code":374,"device_name":375,"device_class":8,"k510_count":28},"GCO","Endoscope, Mirror",{"product_code":377,"device_name":378,"device_class":8,"k510_count":28},"NWU","Endoscope Introducer Kit",{"product_code":380,"device_name":381,"device_class":8,"k510_count":382},"FAK","Panendoscope (Gastroduodenoscope)",2,{"product_code":384,"device_name":385,"device_class":8,"k510_count":382},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":387,"device_name":388,"device_class":12,"k510_count":382},"FCP","Box, Battery, Pocket",{"product_code":390,"device_name":391,"device_class":12,"k510_count":382},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":393,"device_name":394,"device_class":12,"k510_count":382},"FEA","Attachment, Teaching, For Endoscope",{"product_code":396,"device_name":397,"device_class":12,"k510_count":382},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":399,"device_name":400,"device_class":12,"k510_count":382},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":402,"device_name":403,"device_class":8,"k510_count":382},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":405,"device_name":406,"device_class":8,"k510_count":382},"FTI","Lamp, Endoscope, Incandescent",{"product_code":408,"device_name":409,"device_class":8,"k510_count":382},"GCF","Proctoscope",{"product_code":411,"device_name":412,"device_class":8,"k510_count":382},"KGD","Scissors For Cystoscope",{"product_code":414,"device_name":415,"device_class":8,"k510_count":382},"NBG","Marker, Colon",{"product_code":417,"device_name":418,"device_class":8,"k510_count":382},"NEQ","Device, Telemedicine, Robotic",{"product_code":420,"device_name":421,"device_class":8,"k510_count":382},"PCV","Endoscopic Leak Tester",{"product_code":423,"device_name":424,"device_class":8,"k510_count":382},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":426,"device_name":427,"device_class":8,"k510_count":428},"FAL","Panendoscope (Urethroscope)",1,{"product_code":430,"device_name":431,"device_class":8,"k510_count":428},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":433,"device_name":434,"device_class":8,"k510_count":428},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":436,"device_name":437,"device_class":12,"k510_count":428},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":439,"device_name":440,"device_class":8,"k510_count":428},"GCW","Transformer, Endoscope",{"product_code":442,"device_name":443,"device_class":8,"k510_count":428},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":445,"device_name":446,"device_class":8,"k510_count":428},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":448,"device_name":449,"device_class":8,"k510_count":428},"KYH","Endoscope, Ophthalmic",{"product_code":451,"device_name":452,"device_class":8,"k510_count":428},"MFJ","Device, Endoscopic Suturing",{"product_code":454,"device_name":455,"device_class":8,"k510_count":428},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":457,"device_name":133,"device_class":8,"k510_count":428},"OCS",{"product_code":459,"device_name":460,"device_class":8,"k510_count":428},"PGU","Spatial Imaging For Display Of Endoscope Position",{"product_code":462,"device_name":463,"device_class":8,"k510_count":428},"PUP","Endoscope Maintenance System",{"product_code":465,"device_name":466,"device_class":8,"k510_count":428},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":468,"device_name":469,"device_class":8,"k510_count":428},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":471,"device_name":472,"device_class":12,"k510_count":26},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":474,"device_name":475,"device_class":8,"k510_count":26},"FBI","Rongeur, Cystoscopic",{"product_code":477,"device_name":478,"device_class":12,"k510_count":26},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":480,"device_name":481,"device_class":8,"k510_count":26},"FDR","Sphyncteroscope",{"product_code":483,"device_name":484,"device_class":8,"k510_count":26},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":486,"device_name":487,"device_class":12,"k510_count":26},"FDY","Device, Measuring, For Panendoscope",{"product_code":489,"device_name":490,"device_class":8,"k510_count":26},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":492,"device_name":493,"device_class":8,"k510_count":26},"GCG","Peritoneoscope",{"product_code":495,"device_name":496,"device_class":8,"k510_count":26},"GCH","Mediastinoscope, Diagnostic",{"product_code":498,"device_name":499,"device_class":8,"k510_count":26},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":501,"device_name":502,"device_class":8,"k510_count":26},"GCN","Endoscope, Prism",{"product_code":504,"device_name":505,"device_class":8,"k510_count":26},"NKZ","Endoilluminator, Reprocessed",{"product_code":507,"device_name":508,"device_class":8,"k510_count":26},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":510,"device_name":511,"device_class":8,"k510_count":26},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":513,"device_name":514,"device_class":8,"k510_count":26},"NWT","Endoscopic Cholangiogram Kit",{"product_code":516,"device_name":517,"device_class":12,"k510_count":26},"PHT","Basin For Endoscope Reprocessing",{"product_code":519,"device_name":520,"device_class":8,"k510_count":26},"PPE","Nephroscope Set",{"product_code":522,"device_name":523,"device_class":8,"k510_count":26},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":525,"device_name":526,"device_class":8,"k510_count":26},"PTR","Scissors For Cytoscope, Exempt",{"product_code":528,"device_name":529,"device_class":8,"k510_count":26},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":531,"device_name":532,"device_class":8,"k510_count":26},"SBX","Software For Endoscopy Procedure Metrics",{"510k":534,"classification":535,"enforcement":536,"event":537,"pma":538,"warning_letter":539},"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":541,"definition_ja":542,"commentary_ja":543,"model_name":544,"source_hash":545,"reviewed_by":27,"reviewed_at":27,"created_at":546,"updated_at":546},"内視鏡用磁性異物摘出器","内視鏡的に磁性の異物を摘出するためのものである。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）による審査を経て市場に出すことが可能な医療機器です。クラスIIは、クラスIに比べて人体へのリスクがやや高く、有効性や安全性を確認するために既存の同等品との実質的同等性を示す必要がある区分です。","claude-sonnet-5","446271f9ae2b63d26a27ce765c3b94429f05ab5de7408f8180ca65d2c0764d7e","2026-08-24T01:50:05.227637+00:00",{"product_code":6,"summary_ja":548,"stats":549,"stats_hash":558,"model_name":544,"created_at":559,"updated_at":559},"本製品は510(k)による届出品目で、累計3件の届出があり、参入企業数は3社となっています。ただし直近5年間での届出はなく、最新の判定は1991年3月です。不具合報告および回収については、いずれも報告・実施例が確認されていません。",{"pma":550,"k510":551,"as_of":553,"events":554,"recalls":555,"top_problems":557},{"latest":27,"originals":26,"supplements":26},{"total":28,"last5y":26,"latest":552,"applicants":28},"1991-03-21","2026-08",{"death":26,"other":26,"total":26,"injury":26,"last5y":26,"malfunction":26,"latest_month":27},{"total":26,"last5y":26,"latest":27,"class_i":26,"class_ii":26,"class_iii":26,"top_root_causes":556},[],[],"ddfc51bae3d4f80705235b17d29a2202039591636a897741087fffd90e2e59e5","2026-08-24T04:18:34.328284+00:00",{"items":561,"total":26},[],{"items":563,"total":28},[564,569,573],{"k_number":18,"device_name":565,"applicant":566,"decision_date":552,"clearance_type":567,"decision_code":568,"statement_or_summary":27},"IE MAGNETIC EXTRACTOR","Olympus Corp.","Traditional","SESE",{"k_number":19,"device_name":570,"applicant":571,"decision_date":572,"clearance_type":567,"decision_code":568,"statement_or_summary":27},"BRIMFIELD CANNULATED MAGNETIC RETRIEVER","Brimfield Scientific Instruments","1984-09-26",{"k_number":20,"device_name":574,"applicant":575,"decision_date":576,"clearance_type":567,"decision_code":568,"statement_or_summary":27},"M.R. ASSOC. MAGNETIC EXTRACTOR","Mr Associates, Inc.","1980-05-08",{"items":578,"total":26},[]]