ETAClass II

Replacement, Ossicular Prosthesis, Total

21 CFR 874.3495 / Ear, Nose, Throat

ETA is the FDA product code for Replacement, Ossicular Prosthesis, Total, a class II device type, regulated under 21 CFR 874.3495. As of 2026-09-10, FDA records hold 39 510(k) clearances under this code, the most recent dated 2026-04-03, and 2 recalls.

Classification record

Product code: ETA
Device name: Replacement, Ossicular Prosthesis, Total
Regulation: 21 CFR 874.3495
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 39
Ingested recalls: 2

Clearances, product code ETA

By decision year

39 clearances under product code ETA with a decision year between 1976 and 2026, 1983 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code ETA by decision year
Year	Clearances
1976	1
1981	1
1983	4
1985	1
1987	2
1989	3
1991	3
1994	2
1995	4
1997	3
1998	1
1999	3
2000	4
2003	1
2004	1
2005	1
2009	2
2025	1
2026	1

Applicants with the most clearances

Product code ETA

Applicants holding the most 510(k) clearances under product code ETA
Applicant	Clearances
Treace Medical, Inc.	4
Gyrus Ent LLC	3
Mednet Locator, Inc.	3
Microbio-Medics, Inc.	3
Smith & Nephew Richards, Inc.	3
Exmoor Plastics Limited	2
Heinz Kurz GmbH Medizintechnik	2
MED-EL Elektromedizinische Geräte GmbH	2
Richards Medical Co., Inc.	2
American Biomaterials Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order