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Olympus WA50042A

by Olympus Winter & Ibe GmbH

Ref WA50042A

Olympus WA50042A 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 7 Sep 2026 (Basic UDI-DI B-04042761074971), cleared under FDA 510(k) K111788 on 13 Jan 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761074971), active as of 23 Oct 2026. 2 FDA recalls are 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111788

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-04042761074971 Basic UDI-DI 04042761074971UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761074971 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111788 Date13 Jan 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761074971 registered 7 Sep 2026 Active
  • FDA 510(k) K111788 decided 13 Jan 2012 Active
  • FDA GUDID UDI-DI 04042761074971 listed 21 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1929-2017 FDA Class II initiated 10 Feb 2017

    A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

    • Terminated Z-0403-2016 FDA Class II initiated 17 Nov 2015

    A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.

Timeline

5 dated events

  1. Cleared FDA 510(k) K111788
  2. Recall initiated FDA recalls Z-0403-2016
  3. Listed FDA GUDID 04042761074971
  4. Recall initiated FDA recalls Z-1929-2017
  5. Registered EUDAMED B-04042761074971

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
Video telescope, 10 mm, 30°, autoclavable ENDOEYE HD II EUDAMED
Olympus GUDID
Generic name
Rigid video laparoscope
Model / Ref / Catalog
WA50042A
Primary DI / UDI-DI
04042761074971
Basic UDI-DI
B-04042761074971
FDA product code
HET
EMDN code
Z12029016 Video laparoscopes
GMDN term
Rigid video laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1720
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 video laparoscope

Cleared under the same submission (K111788)

Similar devices in this category

Other devices filed under VIDEO LAPAROSCOPES.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

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