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Gyrus ACMI BPS-A

by Gyrus Acmi, Inc.

Ref BPS-A

Gyrus ACMI BPS-A is a device classified as Class I in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00821925027312), cleared under FDA 510(k) K012929 on 19 Nov 2001 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 00821925027312), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K012929

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925027312 Basic UDI-DI 00821925027312UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925027312 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK012929 Date19 Nov 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925027312 registered 2 Nov 2026 Active
  • FDA 510(k) K012929 decided 19 Nov 2001 Active
  • FDA GUDID UDI-DI 00821925027312 listed 13 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K012929
  2. Listed FDA GUDID 00821925027312
  3. Registered EUDAMED B-00821925027312

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Gyrus ACMI
Generic name
Rigid optical ureteroscope
Device name
Bps-A
Model / reference
BPS-A
Primary DI / UDI-DI
00821925027312 EUDAMED
00821925031500 GUDID
Basic UDI-DI
B-00821925027312
510(k) Number
FDA product code
FAJ
EMDN code
U090399 Single-use instruments for urogenital endoscopy - other
GMDN term
Rigid optical ureteroscope
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925027312
GUDID
00821925031500
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925027312; FDA GUDID lists 00821925031500), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rigid optical ureteroscope

Cleared under the same submission (K012929)

Similar devices in this category

Other devices filed under SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY.

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 (20, all answered No)