Cleared Traditional

K123163 - NEUROPACE BURR HOLE COVER MODEL 8110

K123163 is an FDA 510(k) clearance for NEUROPACE BURR HOLE COVER MODEL 8110, manufactured by NeuroPace, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K123163 · NeuroPace, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
101d
Days
Class 2
Risk

K123163 is an FDA 510(k) clearance for the NEUROPACE BURR HOLE COVER MODEL 8110. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by NeuroPace, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K123163

510(k) Number K123163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date January 18, 2013
Days to Decision 101 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 149d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXR Cover, Burr Hole

All 28
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K123163.
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CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
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AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
K071138 · Prosurg, Inc. · Aug 2007
K123163 · NEUROPACE BURR HOLE COVER MODEL 8110
Download PDF FDA Summary NeuroPace, Inc.