510(k) K251191

Collagen Dura Regeneration Membrane - Repair by Collagen Matrix, Inc. — Product Code GXQ

K251191 is an FDA 510(k) premarket notification submitted by Collagen Matrix, Inc. for the device "Collagen Dura Regeneration Membrane - Repair". The FDA issued a decision of Substantially Equivalent on November 18, 2025. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Collagen Matrix, Inc. has at least 10 other 510(k) clearances on record.