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Olympus WA51138A

by Olympus Winter & Ibe GmbH

Ref WA51138A

Olympus WA51138A is a device classified as Class IIb in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 40427611102852), cleared under FDA 510(k) K923982 on 15 Mar 1993 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761024341), active as of 23 Oct 2026.

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

CE MDR 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) K923982

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/MDR EUDAMED Number40427611102852 Basic UDI-DI 04042761024341UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761024341 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK923982 Date15 Mar 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 40427611102852 registered 13 May 2026 Active
  • FDA 510(k) K923982 decided 15 Mar 1993 Active
  • FDA GUDID UDI-DI 04042761024341 listed 21 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1163-2010 FDA Unclassified (pre-2012) initiated 8 Feb 2010 on shared 510(k) K923982

    weak weld seams

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K923982
  2. Recall initiated FDA recalls Z-1163-2010
  3. Listed FDA GUDID 04042761024341
  4. Registered EUDAMED 40427611102852

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Suction/irrigation tube 5.3 x 360 mm, button, unipolar, for HiQ+ handle EUDAMED
Olympus GUDID
Generic name
Suction cannula, reusable
Device name
Suction/Irrigation HiQ - tube monopolar
Model / Ref / Catalog
WA51138A
Primary DI / UDI-DI
04042761024341
Basic UDI-DI
40427611102852
Direct marketing DI
04042761024341
510(k) Number
FDA product code
GCJ
EMDN code
L180502 Endoscopic electrosurgery multifunctional cannulas, reusable
GMDN term
Suction cannula, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Suction cannula, reusable

Cleared under the same submission (K923982)

and 8 more cleared under K923982

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS, REUSABLE.

Other devices from Olympus Winter & Ibe GmbH

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    Class II

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    Class II

  • Oes Elite WA2C17BS

    Class II

  • Oes Elite WA2C21BS

    Class II

See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)