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FR 26807、https:\u002F\u002Fwww.gpo.gov\u002Ffdsys\u002Fpkg\u002FFR-2017-06-09\u002Fpdf\u002F2017-12007.pdf で入手可能）。","本製品は米国FDAにおいてクラスIIに分類されており、市販前届出（510(k)）による審査を経て市場に流通します。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区分であり、一般的な管理に加えて性能規格や特別管理要件を満たすことで安全性と有効性が確認される仕組みとなっています。再使用可能な機器について再処理手順のバリデーションデータの提出が求められている点は、この特別管理要件の具体例の一つです。","claude-sonnet-5","afe18c77e53bb1fd9a0c135b9e1f0dfa0e1305df627c969fd97bc71bd7f43c3b","2026-08-24T01:50:05.227637+00:00",{"product_code":6,"summary_ja":165,"stats":166,"stats_hash":185,"model_name":161,"created_at":186,"updated_at":186},"510(k)の累計件数は約10件で、7社が参入しており、直近5年間では約2件の届出が確認されています。不具合報告は累計約360件で、大半がMalfunction（不具合）であり、死亡報告は0件、傷害は約20件となっています。主な問題としてはBreak（破損）、Detachment of Device or Device Component（部品の脱落）、Crack（亀裂）が挙げられています。回収については累計件数が0件であり、報告されているクラスI・II・IIIの事例は確認されていません。",{"pma":167,"k510":168,"as_of":172,"events":173,"recalls":179,"top_problems":181},{"latest":65,"originals":64,"supplements":64},{"total":66,"last5y":169,"latest":170,"applicants":171},2,"2026-03-02",7,"2026-08",{"death":64,"other":174,"total":67,"injury":175,"last5y":176,"malfunction":177,"latest_month":178},1,23,342,340,"2026-05",{"total":64,"last5y":64,"latest":65,"class_i":64,"class_ii":64,"class_iii":64,"top_root_causes":180},[],[182,183,184],"Break","Detachment of Device or Device Component","Crack","985ec3d69b324c0a10ec76dcc4201395507ae4985ca46037ae4ec59eedd7c4f0","2026-08-24T04:18:34.328284+00:00",{"items":188,"total":64},[],{"items":190,"total":66},[191,197,201,203,207,212,215,219,223,227,231],{"k_number":23,"device_name":192,"applicant":193,"decision_date":170,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"KARL STORZ Mediastinoscopes and Instruments","Karl Storz SE & 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KG","Traditional","SESE","Summary",{"k_number":25,"device_name":198,"applicant":199,"decision_date":200,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"HD Mediastinoscope","Karl Storz Endoscopy America, Inc.","2022-06-23",{"k_number":21,"device_name":198,"applicant":199,"decision_date":202,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"2021-05-11",{"k_number":28,"device_name":204,"applicant":205,"decision_date":206,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"Aegis Transit System","Boston-Biomedical Associates","2017-07-14",{"k_number":22,"device_name":208,"applicant":209,"decision_date":210,"clearance_type":211,"decision_code":195,"statement_or_summary":196},"Illuminated Mediastinal Access Port","Aegis Surgical, Ltd.","2016-02-26","Special",{"k_number":24,"device_name":213,"applicant":209,"decision_date":214,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"ILLUMINATED MEDIASTINOSCOPE","2015-01-09",{"k_number":19,"device_name":216,"applicant":217,"decision_date":218,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION\u002FOCULAR EYEPIECE","Richard Wolf Medical Instruments Corp.","1997-08-27",{"k_number":26,"device_name":220,"applicant":221,"decision_date":222,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"KARL STORZ OPTICAL MEDIASTINOSCOPE","KARL STORZ Endoscopy-America, Inc.","1995-11-03",{"k_number":18,"device_name":224,"applicant":225,"decision_date":226,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"FLEXIBLE TROCAR TUBES","Olympus Corp.","1993-03-16",{"k_number":27,"device_name":228,"applicant":225,"decision_date":229,"clearance_type":194,"decision_code":195,"statement_or_summary":230},"OLYMPUS FLEXIBLE TIP THORACOSCOPE","1991-11-22","Statement",{"k_number":20,"device_name":232,"applicant":225,"decision_date":233,"clearance_type":194,"decision_code":195,"statement_or_summary":230},"OES THORACOSCOPE SYSTEM","1991-10-24",{"items":235,"total":64},[]]