FDA 510(k)

絲綢外科縫線

K 號：K162396 · 2016-11-23

決定日期2016-11-23

產品代碼GAP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SILK Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K162396. 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 SILK Surgical Suture?

SILK Surgical Suture is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162396.

When did SILK Surgical Suture receive FDA 510(k) clearance?

SILK Surgical Suture received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162396.

Who is the listed applicant for SILK Surgical Suture?

The FDA 510(k) record lists Teleflexmedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILK Surgical Suture?

The FDA product code for SILK Surgical Suture is GAP.

其他以 Teleflexmedical, Inc. 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。

K232469魯施天然乳膠金屬福樸導尿管 K212077泰勒弗萊克斯魯斯柔簡塑福利歐導尿管 K192324雪倫螺旋柔軟氣管內管 K182847Hudson RCI Voldyne體積訓練器 K181979魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管 K183461魯士Flocath親水性間歇性導尿管，魯士MMG親水性間歇性導尿管

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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。

K241486Sofsilk™ 包覆織錯絲縫線Covidien 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.

官方來源

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