Neuropace Burr Hole Cover

FDA 510(k) K141368 · NeuroPace, Inc.

Substantially Equivalent

510(k) numberK141368

Submission

Device name
Neuropace Burr Hole Cover
Applicant
NeuroPace, Inc.
Mountain View, CA, US
Received
May 23, 2014
Decision date
July 11, 2014
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXR – Cover, Burr Hole
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5250
Specialty
Neurology
Implant
Yes

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K221606Absorbable Cranial Flap Fixation SystemGXR · Traditional Chendu Medart Medical Scientific Co., Ltd.11/21/2023SE
K192310Flap Fixator, Burr Hole CoverGXR · Traditional Ossaware Biotech Co., Ltd.06/03/2020SE
K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional Neurovention, LLC03/13/2020SE
K181539OSSDSIGN CranioplugGXR · Traditional Ossdsign AB10/12/2018SE
K181382GuardianTM Burr Hole Cover SystemGXR · Abbreviated St Jude Medical07/20/2018SE
K160739Cranial COVERGXR · Traditional Neos Surgery S.L06/12/2016SE
K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional St Jude Medical06/09/2016SE
K140309CranioplugGXR · Traditional Ossdsign AB10/03/2014SE

More from Ossdsign AB

510(k)DeviceDecision
K123163Neuropace Burr Hole Cover Model 8110GXR · Traditional 01/18/2013SE

Questions and answers

When was Neuropace Burr Hole Cover cleared by the FDA?

Neuropace Burr Hole Cover (K141368) received a 510(k) decision of Substantially Equivalent on July 11, 2014, 49 days after the submission was received.

What is the product code of K141368?

The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.