510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933595Substantially Equivalent

Bur, Surgical, General & Plastic Surgery

Omega Surgical Instruments, Inc., Fenton MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933595 is the FDA 510(k) clearance record for BUR, SURGICAL, GENERAL & PLASTIC SURGERY, a class I device, cleared for Omega Surgical Instruments, Inc. on under FDA product code GFA (Blade, Saw, General & Plastic Surgery, Surgical). FDA records list 3 510(k) clearances for Omega Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K933595.

Clearance record

Decision date
Received
(233 days to decision)
Product code
GFA Blade, Saw, General & Plastic Surgery, Surgical
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Omega Surgical Instruments, Inc. 11415 Orchardview Dr., Fenton MI
510(k) summary
Statement
Third party review
No

Clearances, product code GFA

Trailing 12 months

FDA records hold no clearances under product code GFA in the trailing twelve months.

FDA records show no clearances under product code GFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GFA, 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 20260
October 20260