510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834094Substantially Equivalent

Austin Endolymph Dispersment Shunt

Treace Medical, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834094 is the FDA 510(k) clearance record for AUSTIN ENDOLYMPH DISPERSMENT SHUNT, a class II device, cleared for Treace Medical, Inc. on under FDA product code ESZ (Tube, Shunt, Endolymphatic). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K834094.

Clearance record

Decision date
Received
(297 days to decision)
Product code
ESZ Tube, Shunt, Endolymphatic
Regulation
21 CFR 874.3820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Treace Medical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ESZ

Trailing 12 months

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

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