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Gyrus ACMI 140875

by Gyrus Acmi, Inc.

Gyrus ACMI 140875 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 00821925015777), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K910685

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821925015777 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK910685 Date4 Dec 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K910685 decided 4 Dec 1991 Active
  • FDA GUDID UDI-DI 00821925015777 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K910685
  2. Listed FDA GUDID 00821925015777

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gyrus ACMI
Generic name
Ossicular prosthesis, partial
Model / reference
140875
Primary DI / UDI-DI
00821925015777
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

Related devices

Category: Ossicular prosthesis, partial

Cleared under the same submission (K910685)

and 8 more cleared under K910685

Similar devices

Other devices filed under FDA product code ETB (Prosthesis, Partial Ossicular Replacement).

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)