FDA 510(k)

解決內視鏡止血系統

K 號：K234131 · 2024-07-26

決定日期2024-07-26

產品代碼QAU

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

Resolv Endoscopic Hemostat System is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K234131. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Resolv Endoscopic Hemostat System?

Resolv Endoscopic Hemostat System is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Hemostasis, LLC. The 510(k) number is K234131.

When did Resolv Endoscopic Hemostat System receive FDA 510(k) clearance?

Resolv Endoscopic Hemostat System received FDA 510(k) clearance on 2024-07-26, under 510(k) number K234131.

Who is the listed applicant for Resolv Endoscopic Hemostat System?

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

What is the FDA product code for Resolv Endoscopic Hemostat System?

The FDA product code for Resolv Endoscopic Hemostat System is QAU.

其他以 Hemostasis, 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。

K220326PosiSep X BAM 止血敷料/鼻內支撐 K210411PosiSep 耳部碎裂敷料

相關器械（代碼：QAU）

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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