Sofsilk™ 包覆織錯絲縫線
K 號：K241486 · 2024-12-03
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器材摘要
Sofsilk™ Coated Braided Silk Suture is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2024-12-03 under 510(k) number K241486. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sofsilk™ Coated Braided Silk Suture?
Sofsilk™ Coated Braided Silk Suture is a medical device that received FDA 510(k) clearance on 2024-12-03. The listed applicant is Covidien. The 510(k) number is K241486.
When did Sofsilk™ Coated Braided Silk Suture receive FDA 510(k) clearance?
Sofsilk™ Coated Braided Silk Suture received FDA 510(k) clearance on 2024-12-03, under 510(k) number K241486.
Who is the listed applicant for Sofsilk™ Coated Braided Silk Suture?
The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sofsilk™ Coated Braided Silk Suture?
The FDA product code for Sofsilk™ Coated Braided Silk Suture is GAP.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
其他以 Covidien 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：GAP）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
K222944SafePath 穿織系統-絲縫線，SafePath 穿織系統尼龍縫線 (尼龍) SafePath 穿織系統- 聚丙烯縫線Safepath Medical, Inc.K232355不可吸收外科絲綫縫針Shandong Haidike Medical Product Co., Ltd.K221767外科縫線，含或不帶針Huaian Seamen Medical Technology Co., Ltd.K180701安全通縫合系統Safepath Medical, Inc.K172149FILASILK - 天然不吸收性絲綢外科縫線，FILAMIDE - 不吸收性尼龍外科縫線，MERICRON XL - 不吸收性聚酯外科縫線，FILAPROP - 不吸收性聚丙烯外科縫線M/s. Meril Endo Surgery Private Limited.K162396絲綢外科縫線Teleflexmedical, Inc.
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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