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510(k) K123163

NEUROPACE BURR HOLE COVER MODEL 8110 by NeuroPace, Inc. — Product Code GXR

K123163 is an FDA 510(k) premarket notification submitted by NeuroPace, Inc. for the device "NEUROPACE BURR HOLE COVER MODEL 8110". The FDA issued a decision of Substantially Equivalent on January 18, 2013. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. NeuroPace, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2013
Date Received
October 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

Other clearances by NeuroPace, Inc.

  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)

Other clearances for product code GXR

  • K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (March 16, 2026)
  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221606 — Absorbable Cranial Flap Fixation System (November 21, 2023)
  • K192310 — Flap Fixator, Burr Hole Cover (June 3, 2020)
  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K160739 — Cranial COVER (June 12, 2016)
  • K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (June 9, 2016)
  • K140309 — CRANIOPLUG (October 3, 2014)

FDA data resources