Skip to content

Gyrus ACMI AUR-BP

by Gyrus Acmi, Inc.

Gyrus ACMI AUR-BP is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K012929 on 19 Nov 2001 and listed in FDA GUDID since 25 Jul 2024 (UDI-DI 00821925037441), 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) K012929

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 Number00821925037441 UDI-DI Date25 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012929 Date19 Nov 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012929 decided 19 Nov 2001 Active
  • FDA GUDID UDI-DI 00821925037441 listed 25 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012929
  2. Listed FDA GUDID 00821925037441

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  • Withdrawn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
Rigid optical cystoscope
Model / reference
AUR-BP
Primary DI / UDI-DI
00821925037441
510(k) Number
FDA product code
FAJ
GMDN term
Rigid optical cystoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical cystoscope

Cleared under the same submission (K012929)

Similar devices

Other devices filed under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)