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FDA 510(k)

SafePath 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

K 號：K222944 · 2024-10-18

申請人Safepath Medical, Inc.
決定日期2024-10-18
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

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is the device name listed in this FDA 510(k) record. The listed applicant is Safepath Medical, Inc.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K222944. 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 SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Safepath Medical, Inc.. The 510(k) number is K222944.

When did SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture receive FDA 510(k) clearance?

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture received FDA 510(k) clearance on 2024-10-18, under 510(k) number K222944.

Who is the listed applicant for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

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

What is the FDA product code for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

The FDA product code for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene 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 Safepath Medical, 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。

K180701安全通縫合系統

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CovidienK232355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

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