[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OMD":3},{"classification":4,"mappedDevices":55,"similarCandidates":56,"relatedClassifications":140,"syncDates":141,"translation":148,"marketSummary":155,"recalls":179,"k510s":181,"pmas":219},{"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":49,"updated_at":50,"recall_count":51,"latest_recall_date":52,"k510_count":53,"pma_count":51,"event_count":54},4435,"OMD","Cutaneous Tissue Adhesive With Mesh","2","878.4011","SU","General, Plastic Surgery","1","For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations.  The device may be used in conjunction with, but not in place of, deep dermal sutures.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":46,"device_class":8,"implant_flag":47,"product_code":6,"review_panel":10,"gmp_exempt_flag":47,"third_party_flag":47,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":46,"life_sustain_support_flag":47,"medical_specialty_description":11,"summary_malfunction_reporting":48},{"k_number":17,"fei_number":27,"registration_number":41},[18,19,20,21,22,23,24,25,26],"K211878","K133864","K171442","K152490","K191461","K213512","K163645","DEN090005","K233460",[28,29,30,31,32,33,34,35,36,37,38,39,40],"3010034760","3031294900","3013188547","1417592","3008397795","2210968","1000512168","1000138054","3004530184","3010571423","3017102971","2648650","3013403214",[28,29,30,31,42,33,43,36,38,39,44,40,45],"9617175","1064858","1319639","1061124","","N","Ineligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:48.095002+00:00",0,null,9,2136,[],[57,66,75,83,91,99,108,116,124,132],{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},3795,"皮膚用接着剤","Ⅰ","33492101",0.219512,0.168498,0.779172,0.0317781,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},180,"軟組織接合用接着剤","Ⅳ","34164100",0.390244,0.143357,0.721443,0.031545,{"medical_device_id":76,"generic_name":77,"class_classification":69,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},179,"動脈瘤形成術用組織接着剤","33511000",0.34,0.130769,0.711723,0.0306218,{"medical_device_id":84,"generic_name":85,"class_classification":60,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},4429,"救急絆創膏","34864000",0.204545,0.195513,0.72419,0.03031,{"medical_device_id":92,"generic_name":93,"class_classification":69,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},181,"コラーゲン使用軟組織接合用接着剤","34164200",0.293103,0.150685,0.701692,0.0293865,{"medical_device_id":100,"generic_name":101,"class_classification":102,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},2246,"非固着性創傷被覆・保護材","Ⅱ","11325000",0.183673,0.170819,0.676691,0.0247495,{"medical_device_id":109,"generic_name":110,"class_classification":102,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},2245,"粘着性透明創傷被覆・保護材","17428000",0.178571,0.152542,0.687806,0.0239598,{"medical_device_id":117,"generic_name":118,"class_classification":102,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":123},2224,"取外し可能な皮膚ステープル","35884002",0.0121951,0.266026,0.751158,0.016129,{"medical_device_id":125,"generic_name":126,"class_classification":60,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":131},3818,"皮膚接合用テープ","70438000",0.0344828,0.203065,0.739678,0.015873,{"medical_device_id":133,"generic_name":134,"class_classification":102,"jmdn_code":135,"name_similarity":136,"definition_similarity":137,"vector_similarity":138,"score":139},3005,"経皮的血管内弁カッタ付カテーテル","14339002",0.246377,0.194286,0.595384,0.015625,[],{"510k":142,"classification":143,"enforcement":144,"event":145,"pma":146,"warning_letter":147},"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":149,"definition_ja":150,"commentary_ja":151,"model_name":152,"source_hash":153,"reviewed_by":52,"reviewed_at":52,"created_at":154,"updated_at":154},"メッシュ付き皮膚組織用接着剤","本品は、外用のみに使用し、低侵襲手術による穿刺創を含む外科的切開創、及び十分に洗浄された単純な外傷性裂創等、容易に接合可能な創縁を閉鎖状態に保持するために用いる。本品は深部真皮縫合と併用することができるが、これに代わるものではない。","本品は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）の対象として、既存の合法的販売機器との実質的同等性を示すことにより市販が認められます。510(k)は、クラスIIIの機器に適用される市販前承認（PMA）に比べて簡略化された審査手続きであり、比較的リスクが中程度の医療機器に用いられる仕組みです。","claude-sonnet-5","cd084da0b595a6440edd531e13b50184beadc449889a6167192d83257cd563d1","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":156,"stats":157,"stats_hash":177,"model_name":152,"created_at":178,"updated_at":178},"510(k)の累計届出件数は約9件で、6社が参入しており、直近5年間でも約3件の届出が確認されています。不具合報告は累計約2,100件と多く、その大半が傷害（Injury）で占められ、死亡報告も1件含まれています。主な問題としては、製造・出荷時の汚染（Device Contaminated During Manufacture or Shipping）、非滅菌製品としての出荷（Delivered as Unsterile Product）、材料分離（Material Separation）が挙げられています。回収については累計0件で、該当する記録は確認されていません。",{"pma":158,"k510":159,"as_of":163,"events":164,"recalls":171,"top_problems":173},{"latest":52,"originals":51,"supplements":51},{"total":53,"last5y":160,"latest":161,"applicants":162},3,"2024-07-15",6,"2026-08",{"death":165,"other":166,"total":54,"injury":167,"last5y":168,"malfunction":169,"latest_month":170},1,2,1957,1124,176,"2026-07",{"total":51,"last5y":51,"latest":52,"class_i":51,"class_ii":51,"class_iii":51,"top_root_causes":172},[],[174,175,176],"Device Contaminated During Manufacture or Shipping","Delivered as Unsterile Product","Material Separation","3364edbaf99b30c101db849946605b75970fcdf612cbd00aa1f7f47b57de4ea9","2026-08-24T05:03:24.690751+00:00",{"items":180,"total":51},[],{"items":182,"total":53},[183,189,193,198,202,205,208,210,213],{"k_number":26,"device_name":184,"applicant":185,"decision_date":161,"clearance_type":186,"decision_code":187,"statement_or_summary":188},"CM00622 LINC Skin Closure System (CM00622 LINC)","Connexicon Medical , Ltd.","Traditional","SESE","Summary",{"k_number":18,"device_name":190,"applicant":191,"decision_date":192,"clearance_type":186,"decision_code":187,"statement_or_summary":188},"LiquiBand XL","Advanced Medical Solutions Limited","2022-05-23",{"k_number":23,"device_name":194,"applicant":195,"decision_date":196,"clearance_type":197,"decision_code":187,"statement_or_summary":188},"DERMABOND PRINEO Skin Closure System","ETHICON, Inc.","2021-12-07","Special",{"k_number":22,"device_name":199,"applicant":200,"decision_date":201,"clearance_type":186,"decision_code":187,"statement_or_summary":188},"Exofin Fusion Skin Closure System","Chemence Medical, Inc.","2020-06-05",{"k_number":20,"device_name":199,"applicant":200,"decision_date":203,"clearance_type":204,"decision_code":187,"statement_or_summary":188},"2017-09-25","Abbreviated",{"k_number":24,"device_name":194,"applicant":206,"decision_date":207,"clearance_type":186,"decision_code":187,"statement_or_summary":188},"Ethicon, LLC","2017-04-21",{"k_number":21,"device_name":194,"applicant":195,"decision_date":209,"clearance_type":186,"decision_code":187,"statement_or_summary":188},"2015-11-25",{"k_number":19,"device_name":211,"applicant":195,"decision_date":212,"clearance_type":197,"decision_code":187,"statement_or_summary":188},"DERMABOND PRINEO SKIN CLOSURE SYSTEM","2014-03-10",{"k_number":25,"device_name":214,"applicant":215,"decision_date":216,"clearance_type":217,"decision_code":218,"statement_or_summary":52},"PRINEO SKIN CLOSURE SYSTEM","Closure Medical Corp.","2010-04-30","Post-NSE","DENG",{"items":220,"total":51},[]]