[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PZQ":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":108,"syncDates":109,"translation":116,"marketSummary":123,"recalls":136,"k510s":138,"pmas":145},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},601,"PZQ","General Laparoscopic Power Morcellation Containment System","2","878.4825","SU","General, Plastic Surgery","1","Intended for use as a bag containment system by qualified surgeons for tissue extraction and\u002For power morcellation during general laparoscopic procedures.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":19,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":19,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"DEN170075","","N","Ineligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:48.366308+00:00",0,null,1,[],[29,38,46,55,63,70,78,85,93,100],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":35,"vector_similarity":36,"score":37},3876,"汎用電動式手術台","Ⅰ","36867020",0.2125,0.161943,0.685074,0.0280214,{"medical_device_id":39,"generic_name":40,"class_classification":32,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},3448,"腹腔鏡用へら","36083000",0.212121,0.232673,0.637187,0.026334,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},1227,"据置型デジタル式汎用X線透視診断装置","Ⅱ","37679010",0.26,0.175309,0.577585,0.0163934,{"medical_device_id":56,"generic_name":57,"class_classification":49,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},1223,"移動型デジタル式汎用X線透視診断装置","37646010",0.255102,0.170213,0.59482,0.016129,{"medical_device_id":64,"generic_name":65,"class_classification":49,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":62},2993,"バルーン小腸内視鏡システム","71033002",0.129032,0.212014,0.651923,{"medical_device_id":71,"generic_name":72,"class_classification":49,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},1217,"据置型アナログ式汎用X線透視診断装置","37621010",0.25,0.171913,0.572829,0.015873,{"medical_device_id":79,"generic_name":80,"class_classification":32,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":77},3871,"婦人科用手術台","36618000",0.0843373,0.111801,0.647384,{"medical_device_id":86,"generic_name":87,"class_classification":49,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1219,"移動型アナログ式汎用X線透視診断装置","37622010",0.245098,0.176039,0.587034,0.015625,{"medical_device_id":94,"generic_name":95,"class_classification":32,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":92},4287,"メトロイリンテル","12524000",0.0285714,0.0994152,0.647202,{"medical_device_id":101,"generic_name":102,"class_classification":49,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},1228,"据置型デジタル式汎用一体型X線透視診断装置","37679020",0.242991,0.178049,0.58365,0.0153846,[],{"510k":110,"classification":111,"enforcement":112,"event":113,"pma":114,"warning_letter":115},"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":117,"definition_ja":118,"commentary_ja":119,"model_name":120,"source_hash":121,"reviewed_by":25,"reviewed_at":25,"created_at":122,"updated_at":122},"腹腔鏡下パワーモーセレーション用組織回収バッグシステム","本品は、一般的な腹腔鏡下手術における組織摘出及び／又はパワーモーセレーションのために、資格を有する外科医がバッグ収納システムとして使用することを目的とする。","本品は米国FDAの分類でクラスIIに区分される医療機器です。クラスIIは中等度のリスクを有する機器を対象とする区分であり、多くの場合、既存の同等品との実質的同等性を示す市販前届出（510(k)）の手続きを経て市販が認められます。本品についても、この510(k)による審査区分が適用されています。","claude-sonnet-5","295644088a3db50d1568f27f4b7991f97aaa2deccdf218e8a2ae5f812b922dc9","2026-08-24T02:35:22.423427+00:00",{"product_code":6,"summary_ja":124,"stats":125,"stats_hash":134,"model_name":120,"created_at":135,"updated_at":135},"本製品コードでは、510(k)の累計件数は1件、参入企業数は1社となっており、直近5年間の届出はありません。不具合報告および回収については、いずれも累計件数が0件であり、確認されていません。",{"pma":126,"k510":127,"as_of":129,"events":130,"recalls":131,"top_problems":133},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":128,"applicants":26},"2017-12-19","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":132},[],[],"02571029beaa663b7a0afc68c479c679af7bda2c28d72201efe7feb0933c5b1e","2026-08-24T05:15:00.389328+00:00",{"items":137,"total":24},[],{"items":139,"total":26},[140],{"k_number":18,"device_name":141,"applicant":142,"decision_date":128,"clearance_type":143,"decision_code":144,"statement_or_summary":25},"ContainOR","Advanced Surgical Concepts, Ltd.","Direct","DENG",{"items":146,"total":24},[]]