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510(k) K161370

Durepair Dura Regeneration Matrix by Medtronic Neurosurgery — Product Code GXQ

K161370 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "Durepair Dura Regeneration Matrix". The FDA issued a decision of Substantially Equivalent on November 2, 2016. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2016
Date Received
May 17, 2016
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 Medtronic Neurosurgery

  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242034 — Duet External Drainage and Monitoring System (EDMS) (October 24, 2024)
  • K212641 — StrataMR II Valves and Shunts (September 16, 2021)
  • K181622 — StrataMR guider tool (October 1, 2018)
  • K152700 — StrataMR Valves and Shunts (April 7, 2016)
  • DEN120017 — Medtronic DUET External Drainage and Monitoring System (August 22, 2014)
  • K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (February 13, 2013)
  • K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (November 18, 2011)
  • K091312 — PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (September 2, 2009)
  • K083076 — STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 4 (November 20, 2008)

Other clearances for product code GXQ

  • K251191 — Collagen Dura Regeneration Membrane - Repair (November 18, 2025)
  • 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)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)
  • K150825 — Collagen Dural Regeneration Matrix (November 20, 2015)

FDA data resources