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Gyrus ACMI UBP-SET

by Gyrus Acmi, Inc.

Gyrus ACMI UBP-SET is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K012758 on 9 Apr 2002 and listed in FDA GUDID since 18 Oct 2016 (UDI-DI 00821925038837), 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) K012758

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 Number00821925038837 UDI-DI Date18 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012758 Date9 Apr 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012758 decided 9 Apr 2002 Active
  • FDA GUDID UDI-DI 00821925038837 listed 18 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012758
  2. Listed FDA GUDID 00821925038837

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  • Withdrawn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
Flexible fibreoptic ureteroscope
Model / reference
UBP-SET
Primary DI / UDI-DI
00821925038837
510(k) Number
FDA product code
FGB
GMDN term
Flexible fibreoptic ureteroscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible fibreoptic ureteroscope

Cleared under the same submission (K012758)

Similar devices

Other devices filed under FDA product code FGB (Ureteroscope 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)