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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K251191

510(k) cleared

Collagen Dura Regeneration Membrane - Repair

Collagen Matrix, Inc. · Nov 18, 2025 · K251191

FDA cleared the Collagen Dura Regeneration Membrane - Repair from Collagen Matrix, Inc. on Nov 18, 2025 under K251191, a traditional 510(k). The device falls under product code GXQ, Dura Substitute, regulated at 21 CFR 882.5910 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 17, 2025. The decision came 215 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Collagen Matrix, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251191?

K251191 is the FDA 510(k) for Collagen Dura Regeneration Membrane - Repair, submitted by Collagen Matrix, Inc.. FDA's decision date was Nov 18, 2025, under product code GXQ (Dura Substitute).

Who makes the Collagen Dura Regeneration Membrane - Repair?

Collagen Matrix, Inc., based in Oakland, NJ, is the applicant of record for K251191.

How long did the K251191 review take?

FDA received the submission on Apr 17, 2025 and issued its decision on Nov 18, 2025, 215 days later.

← All decisions in November 2025