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Olympus A4672A

by Olympus Winter & Ibe GmbH

Ref A4672A

Olympus A4672A is a rigid endoscope telescope (EU MDD Class IIa; FDA Class II) made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI B-04042761006347), cleared under FDA 510(k) K950278 on 1 Feb 1995 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761006347), active as of 23 Oct 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K950278

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761006347 Basic UDI-DI 04042761006347UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761006347 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK950278 Date1 Feb 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761006347 registered 3 Sep 2026 Active
  • FDA 510(k) K950278 decided 1 Feb 1995 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761006347 listed 21 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0335-2024 FDA Class II initiated 25 Sep 2023

    Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Timeline

5 dated events

  1. Cleared FDA 510(k) K891451
  2. Cleared FDA 510(k) K950278
  3. Listed FDA GUDID 04042761006347
  4. Recall initiated FDA recalls Z-0335-2024
  5. Registered EUDAMED B-04042761006347

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  • Withdrawn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
Telescope, 3 mm, 0°, autoclavable EUDAMED
Olympus GUDID
Generic name
Rigid endoscope telescope
Model / Ref / Catalog
A4672A
Primary DI / UDI-DI
04042761006347
Basic UDI-DI
B-04042761006347
FDA product code
HIH, GCJ
EMDN code
Z12020704 Hysteroscopes
GMDN term
Rigid endoscope telescope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690, 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 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: Rigid endoscope telescope

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)