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Olympus A22265C

by Olympus Winter & Ibe GmbH

Ref A22265C

Olympus A22265C is a device classified as Class IIa in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-14042761030608), cleared under FDA 510(k) K904939 on 7 Jan 1992 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 14042761030608), active as of 7 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K904939

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-14042761030608 Basic UDI-DI 14042761030608UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14042761030608 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK904939 Date7 Jan 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-14042761030608 registered 5 Nov 2026 Active
  • FDA 510(k) K904939 decided 7 Jan 1992 Active
  • FDA GUDID UDI-DI 14042761030608 listed 21 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-3102-2011 FDA Unclassified (pre-2012) initiated 22 Dec 2010

    The device sterile package seal shows evidence of being breached or was breached

Timeline

4 dated events

  1. Cleared FDA 510(k) K904939
  2. Recall initiated FDA recalls Z-3102-2011
  3. Listed FDA GUDID 14042761030608
  4. Registered EUDAMED B-14042761030608

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  • Withdrawn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
Olympus
Generic name
Manual scalpel blade, single-use
Device name
Knife, 24-28 Fr., 12° and 30°, sterile, single use, 12 pcs.
Model / Ref / Catalog
A22265C
Primary DI / UDI-DI
14042761030608
Basic UDI-DI
B-14042761030608
FDA product code
EZO
EMDN code
U090299 Urogenital endoscopic resection instruments - other
GMDN term
Manual scalpel blade, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.4770
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Manual scalpel blade, single-use

Cleared under the same submission (K904939)

Similar devices in this category

Other devices filed under UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS - OTHER.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)