FDA 510(k)

歐洲聯盟環形釘釘書機，配備三釘技術

K 號：K202507 · 2021-01-21

決定日期2021-01-21

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

EEA Circular Stapler with Tri-Staple Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K202507. 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 EEA Circular Stapler with Tri-Staple Technology?

EEA Circular Stapler with Tri-Staple Technology is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Covidien. The 510(k) number is K202507.

When did EEA Circular Stapler with Tri-Staple Technology receive FDA 510(k) clearance?

EEA Circular Stapler with Tri-Staple Technology received FDA 510(k) clearance on 2021-01-21, under 510(k) number K202507.

Who is the listed applicant for EEA Circular Stapler with Tri-Staple Technology?

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 EEA Circular Stapler with Tri-Staple Technology?

The FDA product code for EEA Circular Stapler with Tri-Staple Technology 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）K232126EEA™環形釘釘器搭配Tri-Staple™技術及OrVil™口腔環形釘釘器底座

查看所有 61 項裝置 →

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

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。