GXQ · Class II · 21 CFR 882.5910

FDA Product Code GXQ: Dura Substitute

Leading manufacturers include Collagen Matrix, Inc., W.L. Gore & Associates, Inc. and Aesculap, Inc..

43
Total
43
Cleared
146d
Avg days
1995
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 153d avg (recent)

FDA 510(k) Cleared Dura Substitute Devices (Product Code GXQ)

43 devices
1–24 of 43
Cleared Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
K251191
Collagen Matrix, Inc.
Neurology · 215d
Cleared May 14, 2025
Helios Dura Regeneration Matrix
K250420
Helios Biomedical, Inc.
Neurology · 90d
Cleared Aug 10, 2023
ArtiFascia
K223445
Nurami Medical , Ltd.
Neurology · 269d
Cleared Jan 28, 2022
SyntheCel Dura Repair
K212943
Synthes USA Products, LLC
Neurology · 135d
Cleared Jun 13, 2019
XenoSure Dura Biologic Patch
K183513
LeMaitre Vascular, Inc.
Neurology · 177d
Cleared Jan 06, 2017
DuraGen Secure Dural Regeneration Matrix
K163456
Integra LifeSciences Corporation
Neurology · 28d
Cleared Nov 20, 2015
Collagen Dural Regeneration Matrix
K150825
Collagen Matrix, Inc.
Neurology · 238d
Cleared Oct 30, 2015
DURAFORM Dural Graft Implant
K152481
Codman & Shurtleff, Inc.
Neurology · 60d
Cleared Jan 16, 2015
COLLAGEN DURA MEMBRANE
K141608
Collagen Matrix, Inc.
Neurology · 214d
Cleared Jun 04, 2013
LYOPLANT ONLAY
K122791
Aesculap, Inc.
Neurology · 265d
Cleared Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
K092388
Integra LifeSciences Corporation
Neurology · 169d
Cleared Jun 26, 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487
Collagen Matrix, Inc.
Neurology · 26d
Cleared Dec 01, 2004
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888
Collagen Matrix, Inc.
Neurology · 240d
Cleared Jun 22, 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518
Codman & Shurtleff, Inc.
Neurology · 15d
Cleared Nov 08, 2002
PRECLUDE MVP DURA SUBSTITUTE
K021477
W.L. Gore & Associates, Inc.
Neurology · 184d
Cleared Mar 13, 2000
CODMAN ETHISORB DURA PATCH
K991413
Johnson & Johnson Professionals, Inc.
Neurology · 325d
Cleared Mar 15, 1999
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534
W.L. Gore & Associates, Inc.
Neurology · 84d
Cleared Dec 09, 1997
LYOPLANT DURA SUBSTITUTE(VARIOUS)
K970851
Aesculap, Inc.
Neurology · 277d
Cleared May 10, 1996
NEURO-PATCH
K960470
Aesculap, Inc.
Neurology · 99d
Cleared Nov 01, 1995
PRECLUDE DURA SUBSTITUTE
K953969
W.L. Gore & Associates, Inc.
Neurology · 71d

About Product Code GXQ - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code GXQ since 1995, with 43 receiving FDA clearance (average review time: 146 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GXQ Product Code

FDA review times for GXQ submissions have been consistent, averaging 153 days recently vs 146 days historically.

GXQ devices are reviewed by the Neurology panel. Browse all Neurology devices →