[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NYS":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":109,"syncDates":110,"translation":117,"marketSummary":124,"recalls":137,"k510s":139,"pmas":146},{"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},5256,"NYS","Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)","2","878.4015","SU","General, Plastic Surgery","1","A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.  The device consists of a textile substrate and permanently bound pdadmac.  The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.",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],"DEN070002","","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:49.169481+00:00",0,null,1,[],[29,38,46,53,61,69,76,85,93,101],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":35,"vector_similarity":36,"score":37},511,"相互作用性創傷被覆・保護材","Ⅲ","34083000",0.202703,0.246291,0.673051,0.031746,{"medical_device_id":39,"generic_name":40,"class_classification":32,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},500,"二次治癒ハイドロゲル創傷被覆・保護材","34082003",0.166667,0.196765,0.663213,0.0305361,{"medical_device_id":47,"generic_name":48,"class_classification":32,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":45},508,"二次治癒フォーム状創傷被覆・保護材","11323003",0.176471,0.195906,0.660283,{"medical_device_id":54,"generic_name":55,"class_classification":32,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},512,"深部体腔創傷被覆・保護材","36226000",0.222222,0.193353,0.638536,0.0289495,{"medical_device_id":62,"generic_name":63,"class_classification":32,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},503,"抗菌性創傷被覆・保護材","34614000",0.148649,0.183801,0.648737,0.0285948,{"medical_device_id":70,"generic_name":71,"class_classification":32,"jmdn_code":72,"name_similarity":73,"definition_similarity":50,"vector_similarity":74,"score":75},510,"創傷被覆・保護材キット","34059000",0.227273,0.634995,0.0282982,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},2251,"局所管理フォーム状創傷被覆・保護材","Ⅱ","11323002",0.125,0.15727,0.652798,0.0266106,{"medical_device_id":86,"generic_name":87,"class_classification":79,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},2253,"創傷保護リング","44273000",0.123288,0.19883,0.649533,0.0264302,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":81,"definition_similarity":98,"vector_similarity":99,"score":100},183,"癒着防止吸収性バリア","Ⅳ","34212000",0.189189,0.646992,0.0261717,{"medical_device_id":102,"generic_name":103,"class_classification":32,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},507,"コラーゲン使用吸収性創傷被覆・保護材","34615200",0.126437,0.20303,0.638451,0.0259916,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"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":118,"definition_ja":119,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":25,"reviewed_at":25,"created_at":123,"updated_at":123},"ポリ塩化ジアリルジメチルアンモニウム(Pdadmac)含有創傷被覆材","ポリ(ジアリルジメチルアンモニウムクロリド)(pdadmac)添加剤を含む創傷被覆材とは、滲出性創傷、第一度および第二度熱傷、ならびに外科的創傷に対する一次被覆材として使用され、一次被覆材の固定およびその移動の防止、ならびに創傷充填材として使用することを意図した、滅菌バリア創傷被覆材である機器をいう。本機器は、繊維基材と永久的に結合したpdadmacから構成される。本機器は外部の汚染物質に対する物理的バリアとして機能するものであり、創傷の表面または内部に作用するものではなく、また身体に作用する抗菌剤を含有するものでもない。","この機器は米国の規制ではクラスIIに分類されており、市販前届出（510(k)）の対象として、既存の同等品との実質的同等性を示すことで市販が認められる審査区分に位置づけられています。クラスIIはクラスIIIに比べてリスクが中程度とされる機器区分であり、PMA（市販前承認）のような厳格な審査を経ずに市場に出すことが可能です。","claude-sonnet-5","8a4529d241756d14e7f6c1637713a04040dc013ef26eaac8e7ac3dbb3ecf6186","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":135,"model_name":121,"created_at":136,"updated_at":136},"本製品コードでは、510(k)の累計件数は1件で、参入企業は1社にとどまり、直近5年の届出実績は確認されていません。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、報告・回収の実績は確認されていません。",{"pma":127,"k510":128,"as_of":130,"events":131,"recalls":132,"top_problems":134},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":129,"applicants":26},"2009-02-25","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":133},[],[],"26efcf00d9c5bfa08515d54eabb2fd1cb9ec7a0dfaa4d18790c59c0b9b30ecce","2026-08-24T05:01:48.414996+00:00",{"items":138,"total":24},[],{"items":140,"total":26},[141],{"k_number":18,"device_name":142,"applicant":143,"decision_date":129,"clearance_type":144,"decision_code":145,"statement_or_summary":25},"QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING","Quick-Med Technologies, Inc.","Post-NSE","DENG",{"items":147,"total":24},[]]