510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853367Substantially Equivalent

H-H Burr Hole Catheter Support

Holter-Hausner Intl., Bridgeport PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853367 is the FDA 510(k) clearance record for H-H BURR HOLE CATHETER SUPPORT, a class II device, cleared for Holter-Hausner Intl. on under FDA product code GXR (Cover, Burr Hole). FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show no recalls naming K853367.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Holter-Hausner Intl. Third And Mill St.S, Bridgeport PA
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