510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002334Substantially Equivalent

Macroporens Craniloc

Macropore Biosurgery, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002334 is the FDA 510(k) clearance record for MACROPORENS CRANILOC, a class II device, cleared for Macropore Biosurgery, Inc. on under FDA product code GXR (Cover, Burr Hole). FDA records list 17 510(k) clearances for Macropore Biosurgery, Inc., from to . As of , FDA records show no recalls naming K002334.

Clearance record

Decision date
Received
(274 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Macropore Biosurgery, Inc. 6740 Top Gun St., San Diego CA
510(k) summary
Summary
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