Gyrus ACMI 140876
Gyrus ACMI 140876 is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K910685 on 4 Dec 1991 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00821925014923), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821925014923 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK910685 | Date4 Dec 1991 | StatusActive |
Official records
- AccessGUDID record 00821925014923
- FDA 510(k) database K910685
Across registries
- FDA 510(k) K910685 decided 4 Dec 1991 Active
- FDA GUDID UDI-DI 00821925014923 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K910685
- Listed FDA GUDID 00821925014923
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gyrus ACMI
- Generic name
- Ossicular prosthesis, partial
- Model / reference
- 140876
- Primary DI / UDI-DI
- 00821925014923
- 510(k) Number
- FDA product code
- ETB
- GMDN term
- Ossicular prosthesis, partial
- Device class
- Class II
- Regulation number
- 874.3450
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ETB (Prosthesis, Partial Ossicular Replacement).
- FISCH MODIFIED TEF-WIRE PISTON by Treace Medical, Inc.
- STAPES PROSTHESES by Grace Medical, Inc.
- PARTIAL OSSICULAR REPLACEMENT PROSTHESES by Grace Medical, Inc.
- SMITH & NEPHEW PORPS & TORPS by Gyrus Ent LLC
- STAINLESS STEEL PISTONS by Humboldt Products
- Nitiflex Stapes Prosthesis by Heinz Kurz GmbH Medizintechnik
- HAPES MALLEABLE INCUS STAPES by Smith & Nephew Richards, Inc.
- MICROTEK STAINLESS STEEL PISTON by Microtek Medical LLC
- INCUS/STAPES PROSTHESIS by Richards Medical Co., Inc.
- PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Anthony D. Prescott