FDA 510(k)

Signia™ 小直徑重裝包，包括標準（圓形）尖端版本

K 號：K222641 · 2022-11-29

決定日期2022-11-29

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

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-11-29 under 510(k) number K222641. 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 Signia™ Small Diameter Reloads Including Regular (Round) Tip Version?

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version is a medical device that received FDA 510(k) clearance on 2022-11-29. The listed applicant is Covidien. The 510(k) number is K222641.

When did Signia™ Small Diameter Reloads Including Regular (Round) Tip Version receive FDA 510(k) clearance?

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version received FDA 510(k) clearance on 2022-11-29, under 510(k) number K222641.

Who is the listed applicant for Signia™ Small Diameter Reloads Including Regular (Round) Tip Version?

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 Signia™ Small Diameter Reloads Including Regular (Round) Tip Version?

The FDA product code for Signia™ Small Diameter Reloads Including Regular (Round) Tip Version is GDW.

其他以 Covidien 為申請人之記錄

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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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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。