FDA 510(k)

膠原蛋白杜拉再生薄膜 - 修復

K 號：K251191 · 2025-11-18

決定日期2025-11-18

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

Collagen Dura Regeneration Membrane - Repair is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K251191. 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 Collagen Dura Regeneration Membrane - Repair?

Collagen Dura Regeneration Membrane - Repair is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K251191.

When did Collagen Dura Regeneration Membrane - Repair receive FDA 510(k) clearance?

Collagen Dura Regeneration Membrane - Repair received FDA 510(k) clearance on 2025-11-18, under 510(k) number K251191.

Who is the listed applicant for Collagen Dura Regeneration Membrane - Repair?

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

What is the FDA product code for Collagen Dura Regeneration Membrane - Repair?

The FDA product code for Collagen Dura Regeneration Membrane - Repair is GXQ.

其他以 Collagen Matrix, Inc. 為申請人之記錄

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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。

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.K163456DuraGen 安全硬膜再生網格Integra LifeSciences Corporation

官方來源

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