Cleared Special

K141368 - NEUROPACE BURR HOLE COVER

K141368 is an FDA 510(k) clearance for NEUROPACE BURR HOLE COVER, manufactured by NeuroPace, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Special 510(k) pathway after a 49-day FDA review.

K141368 · NeuroPace, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
49d
Days
Class 2
Risk

K141368 is an FDA 510(k) clearance for the NEUROPACE BURR HOLE COVER. 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 July 11, 2014 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141368

510(k) Number K141368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date July 11, 2014
Days to Decision 49 days
Submission Type Special
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
100d faster than avg
Panel avg: 149d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 K141368.
Cranial COVER
K160739 · Neos Surgery S.L · Jun 2016
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · St Jude Medical · Jun 2016
CRANIOPLUG
K140309 · Ossdsign AB · Oct 2014
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
K132044 · Neos Surgery S.L · Sep 2013
TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
K123633 · Tissue Regeneration Systems, Inc. · Aug 2013
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · Biomet Microfixation · Jun 2013
K141368 · NEUROPACE BURR HOLE COVER
Download PDF FDA Summary NeuroPace, Inc.