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Olympus A4677A

by Olympus Winter & Ibe GmbH

Ref A4677A

Olympus A4677A 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 3 Sep 2026 (Basic UDI-DI B-04042761006392), cleared under FDA 510(k) K904940 on 13 Jan 1992 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761006392), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K904940

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761006392 Basic UDI-DI 04042761006392UDI-DIDate3 Sep 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04042761006392 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  • EUDAMED Basic UDI-DI B-04042761006392 registered 3 Sep 2026 Withdrawn
  • FDA 510(k) K904940 decided 13 Jan 1992 Active
  • FDA GUDID UDI-DI 04042761006392 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K904940
  2. Listed FDA GUDID 04042761006392
  3. Registered EUDAMED B-04042761006392

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Telescope, 1.9 mm, 30°, 280 mm, autoclavable EUDAMED
Olympus GUDID
Generic name
Rigid endoscope telescope
Model / Ref / Catalog
A4677A
Primary DI / UDI-DI
04042761006392
Basic UDI-DI
B-04042761006392
FDA product code
FJL
EMDN code
Z12020704 Hysteroscopes
GMDN term
Rigid endoscope telescope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
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

Cleared under the same submission (K904940)

and 5 more cleared under K904940

Similar devices in this category

Other devices filed under HYSTEROSCOPES.

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Properties

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