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510(k) K131015

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT by Cook Biotech, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2013
Date Received
April 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dura Substitute
Device Class
Class II
Regulation Number
882.5910
Review Panel
NE
Submission Type

Other clearances by Cook Biotech, Inc.

  • K133306 — SIS HERNIA GRAFT (July 23, 2014)
  • K133011 — DIAPHRAGMATIC HERNIA GRAFT (June 20, 2014)
  • K111695 — HYBRID GRAFT (April 2, 2012)
  • K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (June 20, 2011)
  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (February 27, 2009)
  • K082058 — DYNAMATRIX (October 2, 2008)
  • K073391 — SURGISIS BIODESIGN TISSUE GRAFT (March 21, 2008)
  • K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (October 17, 2007)
  • K070738 — SIS FACIAL CYLINDER, SIS FACIAL IMPLANT (April 5, 2007)

Other clearances for product code GXQ

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  • K250420 — Helios Dura Regeneration Matrix (May 14, 2025)
  • K223445 — ArtiFascia (August 10, 2023)
  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K163456 — DuraGen Secure Dural Regeneration Matrix (January 6, 2017)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)