[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NRN":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":112,"syncDates":113,"translation":120,"marketSummary":127,"recalls":148,"k510s":150,"pmas":165},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},4403,"NRN","Leeches, Medicinal","U","","Unknown","SU","1","The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification.  The animal is a bloodsucking aquatic animal living in fresh water.  The device should be indicated as: \"an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding.\" See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) 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medicinalis）である。この動物は淡水に生息する吸血性の水生動物である。本機器は、「静脈うっ血の問題が治癒を遅延させるおそれがある場合に移植組織の治癒を補助するため、または局所的な出血を持続的に生じさせることにより静脈うっ血の問題を克服するため」に使用されるものとして適応表示されるべきである。連邦官報告示89 FR 106521「医療機器・放射線保健センターから生物製剤評価研究センターへの規制責任の移管：医療用ウジおよび医療用ヒル」（FDA-2024-N-5702）を参照。","本機器は米国においてデバイスクラスが未分類（Unclassified）とされており、21 CFR上の個別の規制番号も付与されていません。未分類とはクラスI・II・IIIのいずれにも正式に区分される前の暫定的な取扱いを意味し、市販に際しては市販前届出（510(k)）の手続きにより既存品との実質的同等性を示すことが求められます。","claude-sonnet-5","156838a0346e3befcbb92d925deb9fc6dc99a7f03c9fc5cd82465f8bccb1c450","2026-08-24T02:18:13.311568+00:00",{"product_code":6,"summary_ja":128,"stats":129,"stats_hash":146,"model_name":124,"created_at":147,"updated_at":147},"本製品コードでは、510(k)による届出が累計3件、申請企業数は3社となっており、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30件で、内訳は傷害が16件、不具合（Malfunction）が13件、その他が4件、死亡報告は0件となっています。主な問題としては、機器の微生物汚染（Microbial Contamination of Device）、機器の取り扱いに関する問題（Device Handling Problem）、制御・治療設定の誤り（Use of Incorrect Control\u002FTreatment Settings）が挙げられています。なお、回収についてはクラスI〜IIIのいずれも報告件数は0件で、実施は確認されていません。",{"pma":130,"k510":131,"as_of":133,"events":134,"recalls":140,"top_problems":142},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":132,"applicants":35},"2015-08-07","2026-08",{"death":33,"other":135,"total":36,"injury":136,"last5y":137,"malfunction":138,"latest_month":139},4,16,14,13,"2025-01",{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":141},[],[143,144,145],"Microbial Contamination of Device","Device Handling Problem","Use of Incorrect Control\u002FTreatment Settings","35dec578d3aa0e0df0029d31a2bcf64f7c366b07726046c3656d3db4adc062ce","2026-08-24T04:59:09.208125+00:00",{"items":149,"total":33},[],{"items":151,"total":35},[152,158,162],{"k_number":19,"device_name":153,"applicant":154,"decision_date":132,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"LEECH, MEDICINAL","Carolina Biological Supply Co.","Traditional","SESE","Summary",{"k_number":20,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"MEDICINAL LEECHES","Biopharm (Uk) , Ltd.","2014-02-19",{"k_number":18,"device_name":159,"applicant":163,"decision_date":164,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"Ricarimpex Sas","2004-06-21",{"items":166,"total":33},[]]