FDA 510(k)

組織膠帶設備

K 號：K203117 · 2021-01-07

決定日期2021-01-07

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

TissueTak device is the device name listed in this FDA 510(k) record. The listed applicant is Via Surgical , Ltd.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K203117. 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 TissueTak device?

TissueTak device is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K203117.

When did TissueTak device receive FDA 510(k) clearance?

TissueTak device received FDA 510(k) clearance on 2021-01-07, under 510(k) number K203117.

Who is the listed applicant for TissueTak device?

The FDA 510(k) record lists Via Surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TissueTak device?

The FDA product code for TissueTak device is GDW.

其他以 Via Surgical , Ltd. 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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