[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QNM":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":120,"syncDates":121,"translation":128,"marketSummary":135,"recalls":153,"k510s":155,"pmas":187},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":40},3771,"QNM","Mountable Electromechanical Surgical System For Transluminal Approaches","2","878.4961","SU","General, Plastic Surgery","1","A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and\u002For operating table-mounted electromechanical surgical system with human\u002Fdevice interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":26,"registration_number":30},[18,19,20,21,22,23,24,25],"DEN190022","K241907","K250591","K242157","K243182","K251056","K251761","K232146",[27,28,29],"3014155960","3003623887","3002807555",[27,28,31],"3008729892","","N","Ineligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:49.169481+00:00",0,null,8,3,[],[43,52,61,69,76,85,92,100,106,114],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},2559,"電動式トレパン","Ⅱ","32821000",0.195402,0.212885,0.685802,0.0244444,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3949,"加速装置用非電動式患者台","Ⅰ","40686000",0.168539,0.270115,0.690516,0.0239316,{"medical_device_id":62,"generic_name":63,"class_classification":55,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},3456,"再使用可能な内視鏡用結石摘出鉗子","37141001",0.0776699,0.226115,0.711528,0.0163934,{"medical_device_id":70,"generic_name":71,"class_classification":55,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":68},3985,"電気手術器用ケーブル及びスイッチ","70657000",0.261905,0.242812,0.66208,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},931,"リターンアラーム付対極板","Ⅲ","11500013",0.247191,0.273256,0.631891,0.016129,{"medical_device_id":86,"generic_name":87,"class_classification":55,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":84},3880,"泌尿器科用診察台","13969000",0.12,0.310256,0.709128,{"medical_device_id":93,"generic_name":94,"class_classification":79,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},936,"機械振動電気手術器","36273000",0.247059,0.252055,0.655425,0.015873,{"medical_device_id":101,"generic_name":102,"class_classification":46,"jmdn_code":103,"name_similarity":37,"definition_similarity":104,"vector_similarity":105,"score":99},1689,"ビデオ硬性腹腔鏡","43053000",0.208443,0.705326,{"medical_device_id":107,"generic_name":108,"class_classification":79,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},1128,"集束超音波治療器","57888003",0.231707,0.233429,0.626446,0.015625,{"medical_device_id":115,"generic_name":116,"class_classification":46,"jmdn_code":117,"name_similarity":37,"definition_similarity":118,"vector_similarity":119,"score":113},1744,"硬性骨盤鏡","35233000",0.209459,0.704237,[],{"510k":122,"classification":123,"enforcement":124,"event":125,"pma":126,"warning_letter":127},"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":129,"definition_ja":130,"commentary_ja":131,"model_name":132,"source_hash":133,"reviewed_by":38,"reviewed_at":38,"created_at":134,"updated_at":134},"経管腔的アプローチ用架台設置型電気機械式手術システム","経管腔的アプローチ用架台設置型電気機械式手術システムとは、ソフトウェア制御による、患者用ベッドおよび／または手術台に設置される電気機械式手術システムであって、資格を有する使用者が電気機械式アームに取り付けられた手術器具を用いて経管腔的内視鏡下手術または腹腔鏡下手術を実施できるようにするヒューマン／デバイスインターフェースを備えるものである。","本品は米国においてデバイスクラスがクラスIIに指定されており、市販前届出（510(k)）による審査区分の対象となっています。510(k)は、既に市販されている同等の機器（プレディケイトデバイス）との実質的同等性を示すことにより市販が認められる審査手続きであり、より厳格な審査を要するクラスIIIの市販前承認（PMA）とは区別されます。","claude-sonnet-5","bd09020f3aae1d28dfdd129afdf434160ef45af75272531fb13be63e29ffb65b","2026-08-24T03:31:52.244646+00:00",{"product_code":6,"summary_ja":136,"stats":137,"stats_hash":151,"model_name":132,"created_at":152,"updated_at":152},"本製品コードの510(k)累計届出件数は8件で、うち7件が直近5年以内に行われており、参入企業は1社となっています。PMAの届出実績は確認されていません。不具合報告（MDR）は累計3件で、内訳は傷害2件、不具合（Malfunction）1件、死亡報告は0件です。主な問題として「機械的問題（Mechanical Problem）」が挙げられており、回収（リコール）の実績は確認されていません。",{"pma":138,"k510":139,"as_of":143,"events":144,"recalls":147,"top_problems":149},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":140,"latest":141,"applicants":142},7,"2025-07-08",1,"2026-08",{"death":37,"other":37,"total":40,"injury":145,"last5y":40,"malfunction":142,"latest_month":146},2,"2026-07",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":148},[],[150],"Mechanical Problem","12265332725463830ec2c90eb8e4f625bad80d857c6cdb7c5f715290329f3c3e","2026-08-24T05:19:21.416523+00:00",{"items":154,"total":37},[],{"items":156,"total":39},[157,163,167,170,173,176,179,182],{"k_number":24,"device_name":158,"applicant":159,"decision_date":141,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode","Momentis Surgical , Ltd.","Special","SESE","Summary",{"k_number":20,"device_name":164,"applicant":159,"decision_date":165,"clearance_type":166,"decision_code":161,"statement_or_summary":162},"Anovo Surgical System  (6Ne)","2025-06-06","Traditional",{"k_number":23,"device_name":168,"applicant":159,"decision_date":169,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode","2025-05-02",{"k_number":22,"device_name":171,"applicant":159,"decision_date":172,"clearance_type":166,"decision_code":161,"statement_or_summary":162},"Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode","2025-02-03",{"k_number":21,"device_name":174,"applicant":159,"decision_date":175,"clearance_type":166,"decision_code":161,"statement_or_summary":162},"Anovo Surgical System (Model 6Ne)","2024-10-21",{"k_number":19,"device_name":177,"applicant":159,"decision_date":178,"clearance_type":166,"decision_code":161,"statement_or_summary":162},"Anovo Surgical System  (model 6N)","2024-10-02",{"k_number":25,"device_name":180,"applicant":159,"decision_date":181,"clearance_type":166,"decision_code":161,"statement_or_summary":162},"Anovo Pedestal","2023-09-14",{"k_number":18,"device_name":183,"applicant":159,"decision_date":184,"clearance_type":185,"decision_code":186,"statement_or_summary":38},"Hominis Surgical System","2021-02-26","Direct","DENG",{"items":188,"total":37},[]]