FDA 510(k)

CoolSeal 揭示

K 號：K203640 · 2021-05-06

決定日期2021-05-06

產品代碼GEI

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

CoolSeal Reveal is the device name listed in this FDA 510(k) record. The listed applicant is Bolder Surgical, LLC. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K203640. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoolSeal Reveal?

CoolSeal Reveal is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K203640.

When did CoolSeal Reveal receive FDA 510(k) clearance?

CoolSeal Reveal received FDA 510(k) clearance on 2021-05-06, under 510(k) number K203640.

Who is the listed applicant for CoolSeal Reveal?

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

What is the FDA product code for CoolSeal Reveal?

The FDA product code for CoolSeal Reveal is GEI.

其他以 Bolder Surgical, LLC 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。

K231012CoolSeal 三位一體 K211579CoolSeal Trinity（30公分桿身），CoolSeal Trinity（37公分桿身），CoolSeal Trinity（44公分桿身）K203183CoolSeal Trinity（30公分桿，37公分桿，以及44公分桿）K202114CoolSeal Generator/CSL-200-50，CoolSeal Trinity（30公分桿）/CSL-TR105-30，CoolSeal Trinity（37公分桿）/CSL-TR105-37，CoolSeal Trinity（44公分桿）/CSL-TR105-44，CoolSeal Mini（20公分桿）/CSL-MN103-20

相關器械（代碼：GEI）

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。

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官方來源

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