FDA 510(k)

Endoform皮膚模板

K 號：K260669 · 2026-06-24

決定日期2026-06-24

產品代碼KGN

決定相當於

器材摘要

Endoform Dermal Template is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K260669. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoform Dermal Template?

Endoform Dermal Template is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K260669.

When did Endoform Dermal Template receive FDA 510(k) clearance?

Endoform Dermal Template received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260669.

Who is the listed applicant for Endoform Dermal Template?

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

What is the FDA product code for Endoform Dermal Template?

The FDA product code for Endoform Dermal Template is KGN.

其他以 Aroa Biosurgery , Ltd. 為申請人之記錄

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相關器械（代碼：KGN）

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596膠原蛋白傷口粉末Ventris Medical K253521ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, Inc.K253974羅斯因膠原蛋白敷料Roosin Medical Co., Ltd.

官方來源

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