FDA 510(k)

AEON™ 維修式內視鏡釘釘

K 號：K251482 · 2025-07-11

決定日期2025-07-11

產品代碼GAG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

AEON™ Endoscopic Powered 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 2025-07-11 under 510(k) number K251482. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AEON™ Endoscopic Powered Stapler?

AEON™ Endoscopic Powered Stapler is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K251482.

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

AEON™ Endoscopic Powered Stapler received FDA 510(k) clearance on 2025-07-11, under 510(k) number K251482.

Who is the listed applicant for AEON™ Endoscopic Powered 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 Powered Stapler?

The FDA product code for AEON™ Endoscopic Powered Stapler is GAG.

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。

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)K222210AEON 維修式內視鏡釘釘 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：GAG）

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。

K253527Tri-Staple™ 2.0 黑色圓形重裝 21mm 過厚 (SIGCIR21XT)；Tri-Staple™ 2.0 黑色圓形重裝 25mm 過厚 (SIGCIR25XT)Covidien, LLC K243596達芬奇SP SureForm 45釘針及重裝盒（SP1098）Intuitive Surgical, Inc.K240881Signia™ 圓形適配器（標準長度）(SIGCIRSTND)；Signia™ 圓形適配器 XL 長度 (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm 縮版釘書機 (ECH45C)；Echelon 3000 45mm 标準釘書機 (ECH45S)；Echelon 3000 45mm 長釘書機 (ECH45L)；Echelon 3000 60mm 縮版釘書機 (ECH60C)；Echelon 3000 60mm 标準釘書機 (ECH60S)；Echelon 3000 60mm 長釘書機 (ECH60L)Ethicon Endo-Surgery, LLC 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)Lexington Medical, Inc.K231934GIA™ 鋳釘器，配備 Tri-Staple™ 技術Covidien

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