FDA 510(k)

DuraGen 安全硬膜再生網格

K 號：K163456 · 2017-01-06

決定日期2017-01-06

產品代碼GXQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

DuraGen Secure Dural Regeneration Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163456. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DuraGen Secure Dural Regeneration Matrix?

DuraGen Secure Dural Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K163456.

When did DuraGen Secure Dural Regeneration Matrix receive FDA 510(k) clearance?

DuraGen Secure Dural Regeneration Matrix received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163456.

Who is the listed applicant for DuraGen Secure Dural Regeneration Matrix?

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

What is the FDA product code for DuraGen Secure Dural Regeneration Matrix?

The FDA product code for DuraGen Secure Dural Regeneration Matrix is GXQ.

其他以 Integra LifeSciences Corporation 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。

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相關器械（代碼：GXQ）

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。

K251191膠原蛋白杜拉再生薄膜 - 修復Collagen Matrix, Inc.K250420赫利俄斯杜拉再生網格Helios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel 持久修復Synthes (USA) Products, LLC K183513XenoSure Dura 生物貼片LeMaitre Vascular, Inc.K172603Cerafix Dura 代用品Acera Surgical, Inc.

官方來源

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