[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JYA":3},{"classification":4,"mappedDevices":88,"similarCandidates":89,"relatedClassifications":162,"syncDates":214,"translation":221,"marketSummary":227,"recalls":240,"k510s":242,"pmas":244},{"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":83,"updated_at":84,"recall_count":85,"latest_recall_date":86,"k510_count":85,"pma_count":85,"event_count":87},2668,"JYA","Scissors, Wire Cutting, Ent, Sterile","1","874.3540","EN","Ear, Nose, Throat","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":81,"product_code":6,"review_panel":10,"gmp_exempt_flag":81,"third_party_flag":81,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":81,"medical_specialty_description":11,"summary_malfunction_reporting":82},{"fei_number":17,"registration_number":58},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"1412854","3002750084","3002806755","3006554912","3006509795","3008936260","3005304066","3022862651","3001620590","3003499455","3004601847","1000119305","1000402972","3003772581","3002808001","3002806862","3008338766","2916714","3004216008","3002806315","2523865","3001236905","1926681","3008902714","3015895045","1317628","3016965929","3013358456","1000179044","3002902735","3008268830","3010699884","3010041511","3029082594","3003944071","3013503739","3002834291","3005747797","3002806816","3007518347",[18,21,59,60,23,61,25,62,63,64,65,66,67,26,68,69,70,34,71,35,72,73,40,41,74,75,42,76,77,78,44,45,79,49,50,51,53,54,80,57],"9610612","9611502","1313525","9614069","1836161","9616250","1423537","9612278","9613926","1932180","9611283","3011137372","9680518","8040278","9710524","8043769","8030607","2431166","9616088","3008808560","9611102","8040233","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:47.513022+00:00",0,null,2,[],[90,98,105,112,118,125,133,141,148,155],{"medical_device_id":91,"generic_name":92,"class_classification":93,"jmdn_code":94,"name_similarity":95,"definition_similarity":85,"vector_similarity":96,"score":97},4211,"ワイヤカッタ","Ⅰ","32885000",0.285714,0.729836,0.0327869,{"medical_device_id":99,"generic_name":100,"class_classification":93,"jmdn_code":101,"name_similarity":102,"definition_similarity":85,"vector_similarity":103,"score":104},4185,"はさみ","35325001",0.272727,0.687042,0.032002,{"medical_device_id":106,"generic_name":107,"class_classification":93,"jmdn_code":108,"name_similarity":109,"definition_similarity":85,"vector_similarity":110,"score":111},4184,"歯科用金冠はさみ","31847000",0.22,0.671026,0.0305504,{"medical_device_id":113,"generic_name":114,"class_classification":93,"jmdn_code":115,"name_similarity":116,"definition_similarity":85,"vector_similarity":117,"score":111},4186,"眼科用せん刀","35327001",0.204545,0.679388,{"medical_device_id":119,"generic_name":120,"class_classification":93,"jmdn_code":121,"name_similarity":122,"definition_similarity":85,"vector_similarity":123,"score":124},4183,"歯科用歯肉はさみ","31822000",0.192308,0.690432,0.0302135,{"medical_device_id":126,"generic_name":127,"class_classification":128,"jmdn_code":129,"name_similarity":130,"definition_similarity":85,"vector_similarity":131,"score":132},2846,"単回使用はさみ","Ⅱ","35325002",0.268293,0.653033,0.0295716,{"medical_device_id":134,"generic_name":135,"class_classification":136,"jmdn_code":137,"name_similarity":138,"definition_similarity":85,"vector_similarity":139,"score":140},478,"滅菌済み絹製縫合糸","Ⅲ","13910000",0.214286,0.652368,0.0288981,{"medical_device_id":142,"generic_name":143,"class_classification":136,"jmdn_code":144,"name_similarity":145,"definition_similarity":85,"vector_similarity":146,"score":147},477,"未滅菌絹製縫合糸","34601000",0.195652,0.651297,0.0280392,{"medical_device_id":149,"generic_name":150,"class_classification":136,"jmdn_code":151,"name_similarity":152,"definition_similarity":85,"vector_similarity":153,"score":154},359,"麻酔用滅菌済み穿刺針","70203003",0.16,0.674478,0.0274328,{"medical_device_id":156,"generic_name":157,"class_classification":128,"jmdn_code":158,"name_similarity":159,"definition_similarity":85,"vector_similarity":160,"score":161},2847,"単回使用眼科用せん刀","35327002",0.211538,0.641543,0.0270563,[163,166,169,172,175,178,181,184,187,190,193,196,199,202,205,208,211],{"product_code":164,"device_name":165,"device_class":8,"k510_count":87},"JXS","Block, Cutting, Ent, Sterile",{"product_code":167,"device_name":168,"device_class":8,"k510_count":85},"JXT","Crimper, Wire, Ent, Sterile",{"product_code":170,"device_name":171,"device_class":8,"k510_count":85},"JXW","Die, Wire Bending, Ent, Sterile",{"product_code":173,"device_name":174,"device_class":8,"k510_count":85},"JXX","Forceps, Wire Closure, Ent, Sterile",{"product_code":176,"device_name":177,"device_class":8,"k510_count":85},"JXY","Jig, Piston Cutting, Ent, Sterile",{"product_code":179,"device_name":180,"device_class":8,"k510_count":85},"JXZ","Punch, Gelfoam, Sterile",{"product_code":182,"device_name":183,"device_class":8,"k510_count":85},"JYB","Vise, Ossicular Finger, Sterile",{"product_code":185,"device_name":186,"device_class":8,"k510_count":85},"LRE","Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile",{"product_code":188,"device_name":189,"device_class":8,"k510_count":85},"NNN","Crimper, Wire, Ent, Non-Sterile",{"product_code":191,"device_name":192,"device_class":8,"k510_count":85},"NNO","Jig, Piston Cutting, Ent, Non-Sterile",{"product_code":194,"device_name":195,"device_class":8,"k510_count":85},"NNP","Die, Wire Bending, Ent, Non-Sterile",{"product_code":197,"device_name":198,"device_class":8,"k510_count":85},"NNQ","Forceps, Wire Closure, Ent, Non-Sterile",{"product_code":200,"device_name":201,"device_class":8,"k510_count":85},"NNR","Block, Cutting, Ent, Non-Sterile",{"product_code":203,"device_name":204,"device_class":8,"k510_count":85},"NNS","Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile",{"product_code":206,"device_name":207,"device_class":8,"k510_count":85},"NNT","Punch, Gelfoam, Non-Sterile",{"product_code":209,"device_name":210,"device_class":8,"k510_count":85},"NNU","Scissors, Wire Cutting, Ent, Non-Sterile",{"product_code":212,"device_name":213,"device_class":8,"k510_count":85},"NNV","Vise, Ossicular Finger, Non-Sterile",{"510k":215,"classification":216,"enforcement":217,"event":218,"pma":219,"warning_letter":220},"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":222,"definition_ja":86,"commentary_ja":223,"model_name":224,"source_hash":225,"reviewed_by":86,"reviewed_at":86,"created_at":226,"updated_at":226},"耳鼻咽喉科用滅菌ワイヤー切断はさみ","本品は耳鼻咽喉科領域において使用される、ワイヤーを切断するための滅菌はさみです。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分に該当します。これは、安全性及び有効性を確保するための一般的な規制（一般的な管理）のみで足りると判断される、リスクの低い医療機器であることを意味します。","claude-sonnet-5","8ed274a55fde06be88e7eaec9946b296516a2807e768b7f29a5427f205d0d132","2026-08-24T02:04:16.411968+00:00",{"product_code":6,"summary_ja":228,"stats":229,"stats_hash":238,"model_name":224,"created_at":239,"updated_at":239},"本製品は届出免除の対象であり、510(k)およびPMAの承認・届出実績は確認されていません。不具合報告は累計2件で、いずれもMalfunction（不具合）に分類されており、死亡・傷害の報告はありません。最新の報告は2015年10月で、直近5年間の報告は確認されていません。回収についても累計件数は0件です。",{"pma":230,"k510":231,"as_of":232,"events":233,"recalls":235,"top_problems":237},{"latest":86,"originals":85,"supplements":85},{"total":85,"last5y":85,"latest":86,"applicants":85},"2026-08",{"death":85,"other":85,"total":87,"injury":85,"last5y":85,"malfunction":87,"latest_month":234},"2015-10",{"total":85,"last5y":85,"latest":86,"class_i":85,"class_ii":85,"class_iii":85,"top_root_causes":236},[],[],"5e24460120aa4c5fccdb4f2304b1e12daf7c7d2b42fc5c67b499e74a56f402cc","2026-08-24T04:43:14.552546+00:00",{"items":241,"total":85},[],{"items":243,"total":85},[],{"items":245,"total":85},[]]