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Gyrus ACMI 140458

by Gyrus Acmi, Inc.

Gyrus ACMI 140458 is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K760433 on 5 Oct 1976 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00821925017306), 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) K760433

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 Number00821925017306 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK760433 Date5 Oct 1976DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K760433 decided 5 Oct 1976 Active
  • FDA GUDID UDI-DI 00821925017306 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K760433
  2. Listed FDA GUDID 00821925017306

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  • Withdrawn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, total
Model / reference
140458
Primary DI / UDI-DI
00821925017306
510(k) Number
FDA product code
ETA
GMDN term
Ossicular prosthesis, total
Device class
Class II
Regulation number
874.3495
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ossicular prosthesis, total

Cleared under the same submission (K760433)

and 8 more cleared under K760433

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)