[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SEJ":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":123,"syncDates":124,"translation":131,"marketSummary":138,"recalls":151,"k510s":153,"pmas":182},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":35},6174,"SEJ","Wound Dressings Containing Topical Analgesics","U","","Unknown","SU","1","A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":11,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":12,"life_sustain_support_flag":31,"medical_specialty_description":10,"summary_malfunction_reporting":32},{"k_number":17,"fei_number":24,"registration_number":28},[18,19,20,21,22,23],"K922636","K092086","K053476","K912565","K001023","K020540",[25,26,27],"3006784948","3000205837","1000138377",[29,25,30],"1648579","1646434","N","Ineligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:48.620842+00:00",0,null,6,[],[40,49,57,65,73,82,90,98,107,115],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},521,"コラーゲン使用熱傷被覆・保護材","Ⅲ","11322203",0.315789,0.289216,0.774916,0.0327869,{"medical_device_id":50,"generic_name":51,"class_classification":43,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},1029,"医薬品含有歯科用歯周保護材料","70872000",0.316667,0.222749,0.724306,0.0302135,{"medical_device_id":58,"generic_name":59,"class_classification":43,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},511,"相互作用性創傷被覆・保護材","34083000",0.263158,0.233333,0.730245,0.0289916,{"medical_device_id":66,"generic_name":67,"class_classification":43,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},507,"コラーゲン使用吸収性創傷被覆・保護材","34615200",0.306452,0.28169,0.710419,0.02886,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},2248,"局所管理生理食塩液含有創傷被覆・保護材","Ⅱ","37298002",0.294118,0.208696,0.720933,0.0288143,{"medical_device_id":83,"generic_name":84,"class_classification":76,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},2247,"局所管理ハイドロゲル創傷被覆・保護材","34082002",0.241935,0.271967,0.732085,0.0285948,{"medical_device_id":91,"generic_name":92,"class_classification":43,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},512,"深部体腔創傷被覆・保護材","36226000",0.290909,0.243119,0.715987,0.0284848,{"medical_device_id":99,"generic_name":100,"class_classification":101,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},3794,"手術用被覆・保護材","Ⅰ","34654000",0.235294,0.19797,0.761209,0.0284455,{"medical_device_id":108,"generic_name":109,"class_classification":43,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},500,"二次治癒ハイドロゲル創傷被覆・保護材","34082003",0.222222,0.290323,0.754008,0.0283716,{"medical_device_id":116,"generic_name":117,"class_classification":43,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},1150,"腹部開放創用ドレッシングキット","47406003",0.295082,0.225705,0.705583,0.0280428,[],{"510k":125,"classification":126,"enforcement":127,"event":128,"pma":129,"warning_letter":130},"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":132,"definition_ja":133,"commentary_ja":134,"model_name":135,"source_hash":136,"reviewed_by":36,"reviewed_at":36,"created_at":137,"updated_at":137},"局所麻酔薬含有創傷被覆材","局所麻酔薬を含有する固形の創傷被覆材は、創傷を覆い保護し、滲出液を吸収し、創傷内の適切な湿潤バランスを維持し、疼痛を軽減するために使用される。局所麻酔薬を含有するゲル、クリームまたは軟膏として調製された創傷被覆材は、創傷内の適切な湿潤バランスを維持し、疼痛を軽減するために使用される。","本品は米国FDAの機器分類上「未分類（Unclassified）」とされており、クラスI・II・IIIのいずれにも明確に区分されていない機器です。審査区分としては市販前届出（510(k)）の対象とされており、既存の同等な機器との実質的同等性を示すことによって市販が認められる仕組みになっています。","claude-sonnet-5","2701679c088285233cb19c5f39d52dde3123183b5fbb340607fb56bedcea180f","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":139,"stats":140,"stats_hash":149,"model_name":135,"created_at":150,"updated_at":150},"510(k)の累計届出件数は6件で、6社が参入していますが、直近5年間の届出はなく、最新の判定は2009年7月となっています。不具合報告および回収は、いずれも累計件数が0件で確認されていません。",{"pma":141,"k510":142,"as_of":144,"events":145,"recalls":146,"top_problems":148},{"latest":36,"originals":35,"supplements":35},{"total":37,"last5y":35,"latest":143,"applicants":37},"2009-07-30","2026-08",{"death":35,"other":35,"total":35,"injury":35,"last5y":35,"malfunction":35,"latest_month":36},{"total":35,"last5y":35,"latest":36,"class_i":35,"class_ii":35,"class_iii":35,"top_root_causes":147},[],[],"d09caa8f9fd8be480164197d51dfeb94624439c9da75778fa4114be02ed74442","2026-08-24T05:23:16.025025+00:00",{"items":152,"total":35},[],{"items":154,"total":37},[155,161,165,169,173,178],{"k_number":19,"device_name":156,"applicant":157,"decision_date":143,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"AMERIGEL WOUND DRESSING PLUS 1\u002F2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027","Amerx Health Care Corp.","Traditional","SESE","Summary",{"k_number":20,"device_name":162,"applicant":163,"decision_date":164,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"ALLWOUND","At Squared, LLC","2006-06-26",{"k_number":23,"device_name":166,"applicant":167,"decision_date":168,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"REGENECARE WOUND GEL","Mpm Medical., Inc.","2002-11-01",{"k_number":22,"device_name":170,"applicant":171,"decision_date":172,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"FREEDOM, MODEL 4660","Johnson & Johnson Consumer Companies, Inc.","2000-09-22",{"k_number":18,"device_name":174,"applicant":175,"decision_date":176,"clearance_type":158,"decision_code":159,"statement_or_summary":177},"HEMO-STAT","Mckinley-Ross Laboratories, Inc.","1992-11-09","Statement",{"k_number":21,"device_name":179,"applicant":180,"decision_date":181,"clearance_type":158,"decision_code":159,"statement_or_summary":177},"MICRO-COLL COLLAGEN WOUND SPRAY","Micro-Coll","1992-06-11",{"items":183,"total":35},[]]