[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LEM":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":114,"syncDates":115,"translation":122,"marketSummary":129,"recalls":143,"k510s":145,"pmas":156},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":30},5932,"LEM","Human Lyophilized Dura Mater","2","882.5975","NE","Neurology","1","Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d).  Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271\"  the good tissue practice regulation http:\u002F\u002Fwww.Fda.Gov\u002Fcber\u002Frules\u002Fgtp.Pdf became final effective may 25, 2005.  It states that \"on january 27, 2004, fda issued an interim final rule excepting human dura mater and human heart valve allografts from the definition of hct\u002Fp in § 1271.3(d) (69 fr 3823). Fda stated that, when the comprehensive framework is in place, fda intends that human dura mater and human heart valves will be subject to it, and that fda intends to revoke the interim rule at that time (69 fr 3823 and 3824). With the effective date of this final rule, fda is revoking the interim rule and revising the language in § 1271.3(d).\"",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":18},[19,20],"K910555","K910447","","Y","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:49.169481+00:00",0,null,2,1,[],[33,42,50,57,65,73,81,89,97,106],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},265,"ヒト硬膜移植片","Ⅳ","36036000",0.485714,0.238494,0.748927,0.0327869,{"medical_device_id":43,"generic_name":44,"class_classification":36,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},270,"ヒト合成人工硬膜","70510000",0.275,0.191176,0.673373,0.032002,{"medical_device_id":51,"generic_name":52,"class_classification":36,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":49},271,"合成人工硬膜","70511000",0.22,0.200837,0.683869,{"medical_device_id":58,"generic_name":59,"class_classification":36,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},1183,"ヒト羊膜使用組織治癒促進用材料","65105004",0.186441,0.154023,0.644575,0.0310096,{"medical_device_id":66,"generic_name":67,"class_classification":36,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},1155,"コラーゲン使用吸収性人工硬膜","45829004",0.161765,0.169102,0.670944,0.0305504,{"medical_device_id":74,"generic_name":75,"class_classification":36,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},1145,"ヒト脱灰骨基質使用吸収性骨再生用材料","47257004",0.190476,0.125,0.603488,0.0153846,{"medical_device_id":82,"generic_name":83,"class_classification":36,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},1186,"再製造中心循環系血管内超音波カテーテル","64174004",0.045977,0.166316,0.638809,0.0151515,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":88},2335,"乾熱滅菌器","Ⅱ","35364000",0.166667,0.1373,0.498728,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},3656,"耳鼻咽喉科用カテーテル","Ⅰ","16432001",0.0408163,0.133949,0.634015,0.0149254,{"medical_device_id":107,"generic_name":108,"class_classification":36,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},95,"中心循環系血管処置用チューブ及びカテーテル","70288000",0.0273973,0.137856,0.633057,0.0147059,[],{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"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":123,"definition_ja":124,"commentary_ja":125,"model_name":126,"source_hash":127,"reviewed_by":28,"reviewed_at":28,"created_at":128,"updated_at":128},"ヒト凍結乾燥硬膜","CBERによる審査が必要である。以前は21 CFR 882.5975に基づき機器として規制されていたが、現在はCBERにおいてセクション361に基づきバンク化されたヒト組織として規制されている。定義は§1271.3(d)を参照。パート1271に基づくドナー適格性、適正組織取扱基準（good tissue practice）、登録およびリスティングの要件に従う。適正組織取扱基準規則（http:\u002F\u002Fwww.fda.gov\u002Fcber\u002Frules\u002Fgtp.pdf）は2005年5月25日に最終規則として発効した。同規則には次のように記載されている。「2004年1月27日、FDAはヒト硬膜およびヒト心臓弁同種移植片を§1271.3(d)のhct\u002Fpの定義から除外する暫定最終規則を発出した（69 FR 3823）。FDAは、包括的な枠組みが整備された時点で、ヒト硬膜およびヒト心臓弁がその枠組みの対象となることを意図しており、その時点で暫定規則を撤回する意向であると述べた（69 FR 3823および3824）。本最終規則の発効日をもって、FDAは暫定規則を撤回し、§1271.3(d)の文言を改訂する。」","本製品は米国においてクラスIIに分類され、510(k)（市販前届出）の対象として位置付けられていますが、上記のとおり現在は公衆衛生法第361条に基づくバンク化ヒト組織（HCT\u002FP）としての規制枠組みに移行しています。クラスIIおよび510(k)という区分は、本製品が機器として規制されていた当時のものであり、クラスIIは中程度のリスクを有する医療機器に適用される分類で、510(k)は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経路です。","claude-sonnet-5","15fbf3ab5ecebccdc645ae3f1d6f8e48ddc79530f39528890d34a07a354839e9","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":130,"stats":131,"stats_hash":141,"model_name":126,"created_at":142,"updated_at":142},"510(k)としてはこれまでに約2件の届出があり、参入企業は2社となっていますが、直近5年間の届出は確認されていません。不具合報告は累計約1件で、その内訳は傷害が1件、死亡や不具合（Malfunction）の報告は確認されておらず、最新の報告は1996年8月です。回収については、累計件数・クラスI〜IIIのいずれも確認されていません。",{"pma":132,"k510":133,"as_of":135,"events":136,"recalls":138,"top_problems":140},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":27,"latest":134,"applicants":29},"1992-06-09","2026-08",{"death":27,"other":27,"total":30,"injury":30,"last5y":27,"malfunction":27,"latest_month":137},"1996-08",{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":139},[],[],"b6803f7c495707d5bba54e7871dab01f562ffb258b959a51bce5717daaa032cf","2026-08-24T04:49:04.081036+00:00",{"items":144,"total":27},[],{"items":146,"total":29},[147,152],{"k_number":20,"device_name":148,"applicant":149,"decision_date":134,"clearance_type":150,"decision_code":151,"statement_or_summary":28},"DURA MATER","Lifelink Foundation Tissue Bank","Traditional","SESE",{"k_number":19,"device_name":153,"applicant":154,"decision_date":155,"clearance_type":150,"decision_code":151,"statement_or_summary":28},"TUTOPLAST DURA","Pfrimmer-Viggo GmbH & Co.","1992-04-20",{"items":157,"total":27},[]]