FDA 510(k)

泰坦SGS

K 號：K210278 · 2021-04-28

決定日期2021-04-28

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

Titan SGS is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K210278. 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 Titan SGS?

Titan SGS is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Standard Bariatrics. The 510(k) number is K210278.

When did Titan SGS receive FDA 510(k) clearance?

Titan SGS received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210278.

Who is the listed applicant for Titan SGS?

The FDA 510(k) record lists Standard Bariatrics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Titan SGS?

The FDA product code for Titan SGS is GDW.

其他以 Standard Bariatrics 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。

K212728標準布吉，38 Fr. 及手壓泵 K210437標準布吉，38 Fr.K200517標準型套管 K191885標準布吉燈 K190788一次性標準夾子 K181608一次性標準夾子

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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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