510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954912Substantially Equivalent

Trebay Irrigated Cutter Blade (Modification)

Trebay Medical Corp., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954912 is the FDA 510(k) clearance record for TREBAY IRRIGATED CUTTER BLADE (MODIFICATION), a class I device, cleared for Trebay Medical Corp. on under FDA product code EQJ (Bur, Ear, Nose And Throat). FDA records list 14 510(k) clearances for Trebay Medical Corp., from to . As of , FDA records show no recalls naming K954912.

Clearance record

Decision date
Received
(44 days to decision)
Product code
EQJ Bur, Ear, Nose And Throat
Regulation
21 CFR 874.4140
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Trebay Medical Corp. 4911 Creekside Dr., Clearwater FL
510(k) summary
Summary
Third party review
No

Clearances, product code EQJ

Trailing 12 months

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

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