FDA 510(k)

三釘2.0重裝版

K 號：K202864 · 2020-10-28

決定日期2020-10-28

產品代碼GDW

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

Tri-Staple 2.0 Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K202864. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tri-Staple 2.0 Reloads?

Tri-Staple 2.0 Reloads is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Covidien. The 510(k) number is K202864.

When did Tri-Staple 2.0 Reloads receive FDA 510(k) clearance?

Tri-Staple 2.0 Reloads received FDA 510(k) clearance on 2020-10-28, under 510(k) number K202864.

Who is the listed applicant for Tri-Staple 2.0 Reloads?

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 Tri-Staple 2.0 Reloads?

The FDA product code for Tri-Staple 2.0 Reloads is GDW.

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。

K241486Sofsilk™ 包覆織錯絲縫線 K240077Mon-a-Therm™ 通用溫度探針 400TM (90050, 90044)K231934GIA™ 鋳釘器，配備 Tri-Staple™ 技術 K231240MaxTack™ 電動固定裝置 K223130Shiley™ 小兒口腔/鼻咽氣管管路配TaperGuard™ 袖，非DEHP（86125，86130，86135，86140，86145，86150，86155，86160）K231491TA™ 鋼釘釘書機及加載單元，配備 DST Series™ 技術

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相關器械（代碼：GDW）

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。

官方來源

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