FDA 510(k)

AEON 維修式內視鏡釘釘

K 號：K222210 · 2023-04-21

決定日期2023-04-21

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

AEON Endoscopic Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Lexington Medical, Inc.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K222210. 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 AEON Endoscopic Stapler?

AEON Endoscopic Stapler is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K222210.

When did AEON Endoscopic Stapler receive FDA 510(k) clearance?

AEON Endoscopic Stapler received FDA 510(k) clearance on 2023-04-21, under 510(k) number K222210.

Who is the listed applicant for AEON Endoscopic Stapler?

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

What is the FDA product code for AEON Endoscopic Stapler?

The FDA product code for AEON Endoscopic Stapler is GDW.

其他以 Lexington Medical, Inc. 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。

K251482AEON™ 維修式內視鏡釘釘 K234039AEON 維修式內視鏡釘釘（短/AEPH060）；AEON 維修式內視鏡釘釘（中/AEPH160）；AEON 維修式內視鏡釘釘（長/AEPH260)K201882AEON 維修式內視鏡釘釘 K192235AEON 腹腔鏡器械 K182380AEON 維修式內視鏡釘釘 K180114AEON 擷取袋

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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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