510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192162Substantially Equivalent

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

Neurovention, LLC, Daytona Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192162 is the FDA 510(k) clearance record for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate, a class II device, cleared for Neurovention, LLC on under FDA product code GXR (Cover, Burr Hole). FDA records list 2 510(k) clearances for Neurovention, LLC, from to . As of , FDA records show no recalls naming K192162.

Clearance record

Decision date
Received
(217 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Neurovention, LLC 645 S. Beach St., Daytona Beach FL
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