Cleared Traditional

Collagen Dura Regeneration Membrane - Repair

K251191 · Collagen Matrix, Inc. · Neurology
Nov 2025
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K251191 is an FDA 510(k) clearance for the Collagen Dura Regeneration Membrane - Repair, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on November 18, 2025, 215 days after receiving the submission on April 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K251191 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2025
Decision Date November 18, 2025
Days to Decision 215 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910