510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001096Substantially Equivalent

Burr Hole Cover, Model Xx

Image-Guided Neurologics, Inc., Melbourne FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001096 is the FDA 510(k) clearance record for BURR HOLE COVER, MODEL XX, a class II device, cleared for Image-Guided Neurologics, Inc. on under FDA product code GXR (Cover, Burr Hole). FDA records list 22 510(k) clearances for Image-Guided Neurologics, Inc., from to . As of , FDA records show one recall naming K001096.

Clearance record

Decision date
Received
(204 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Image-Guided Neurologics, Inc. 2290 Eau Gallie Blvd., Melbourne FL
510(k) summary
Statement
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