FDA 510(k)

Endoform 局部膠質

K 號：K171231 · 2017-06-14

決定日期2017-06-14

產品代碼KGN

決定相當於

器材摘要

Endoform Topical Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K171231. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoform Topical Matrix?

Endoform Topical Matrix is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Aroa Biosurgery. The 510(k) number is K171231.

When did Endoform Topical Matrix receive FDA 510(k) clearance?

Endoform Topical Matrix received FDA 510(k) clearance on 2017-06-14, under 510(k) number K171231.

Who is the listed applicant for Endoform Topical Matrix?

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

What is the FDA product code for Endoform Topical Matrix?

The FDA product code for Endoform Topical Matrix is KGN.

其他以 Aroa Biosurgery 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。

K172318Endoform 銀色皮膚模板

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 K260669Endoform皮膚模板Aroa Biosurgery , Ltd.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.

官方來源

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