510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830332Substantially Equivalent

Budde-Halo Retractor

Ohio Medical Instrument Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830332 is the FDA 510(k) clearance record for BUDDE-HALO RETRACTOR, a class II device, cleared for Ohio Medical Instrument Co., Inc. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 19 510(k) clearances for Ohio Medical Instrument Co., Inc., from to . As of , FDA records show one recall naming K830332.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Ohio Medical Instrument Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GZT

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