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FDA 510(k)

NEUROPACE BURR HOLE COVER MODEL 8110

K-Number: K123163 · 2013-01-18

ApplicantNeuroPace, Inc.
Decision Date2013-01-18
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPACE BURR HOLE COVER MODEL 8110 is the device name listed in this FDA 510(k) record. The listed applicant is NeuroPace, Inc.. It received FDA 510(k) clearance on 2013-01-18 under 510(k) number K123163. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROPACE BURR HOLE COVER MODEL 8110?

NEUROPACE BURR HOLE COVER MODEL 8110 is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is NeuroPace, Inc.. The 510(k) number is K123163.

When did NEUROPACE BURR HOLE COVER MODEL 8110 receive FDA 510(k) clearance?

NEUROPACE BURR HOLE COVER MODEL 8110 received FDA 510(k) clearance on 2013-01-18, under 510(k) number K123163.

Who is the listed applicant for NEUROPACE BURR HOLE COVER MODEL 8110?

The FDA 510(k) record lists NeuroPace, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROPACE BURR HOLE COVER MODEL 8110?

The FDA product code for NEUROPACE BURR HOLE COVER MODEL 8110 is GXR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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