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FDA 510(k)

FILASILK - 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

K 號：K172149 · 2017-10-20

申請人M/s. Meril Endo Surgery Private Limited.
決定日期2017-10-20
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

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K172149. 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 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture?

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K172149.

When did FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture receive FDA 510(k) clearance?

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture received FDA 510(k) clearance on 2017-10-20, under 510(k) number K172149.

Who is the listed applicant for FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture?

The FDA product code for FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 M/s. Meril Endo Surgery Private Limited. 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。

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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CovidienK222944SafePath 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.K162396絲綢外科縫線Teleflexmedical, Inc.

官方來源

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