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Olympus A3550

by Olympus Winter & Ibe GmbH

Ref A3550

Olympus A3550 is a device classified as Class I 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-04042761005234), cleared under FDA 510(k) K904940 on 13 Jan 1992 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761005234), 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) K904940

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-04042761005234 Basic UDI-DI 04042761005234UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761005234 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK904940 Date13 Jan 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761005234 registered 5 Nov 2026 Active
  • FDA 510(k) K904940 decided 13 Jan 1992 Active
  • FDA GUDID UDI-DI 04042761005234 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K904940
  2. Listed FDA GUDID 04042761005234
  3. Registered EUDAMED B-04042761005234

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  • Withdrawn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
Working element, for A3551 EUDAMED
Olympus GUDID
Generic name
Urethrotome
Model / Ref / Catalog
A3550
Primary DI / UDI-DI
04042761005234
Basic UDI-DI
B-04042761005234
510(k) Number
FDA product code
FJL
EMDN code
Z12020702 Cystourethroscopes
GMDN term
Urethrotome
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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: Urethrotome

Cleared under the same submission (K904940)

and 5 more cleared under K904940

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)