510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141368Substantially Equivalent

Neuropace Burr Hole Cover

Neuropace, Mountain View CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141368 is the FDA 510(k) clearance record for NEUROPACE BURR HOLE COVER, a class II device, cleared for NeuroPace, Inc. on under FDA product code GXR (Cover, Burr Hole). FDA records list 2 510(k) clearances for NeuroPace, Inc., from to . As of , FDA records show no recalls naming K141368.

Clearance record

Decision date
Received
(49 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
NeuroPace, Inc. 455 N Bernardo Ave., Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXR

Trailing 12 months
1 clearance under product code GXR in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260