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Olympus WA51131A

by Olympus Winter & Ibe GmbH

Part of a family of 6 devices: see the family page

Ref WA51131A

Olympus WA51131A 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 13 May 2026 (Basic UDI-DI 4042761110274Y), cleared under FDA 510(k) K923982 on 15 Mar 1993 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761024303), 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 Number4042761110274Y Basic UDI-DI 04042761024303UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761024303 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 4042761110274Y registered 13 May 2026 Active
  • FDA 510(k) K923982 decided 15 Mar 1993 Active
  • FDA GUDID UDI-DI 04042761024303 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 04042761024303
  4. Registered EUDAMED 4042761110274Y

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  • Withdrawn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, distal holes, for HiQ+ handle EUDAMED
Olympus GUDID
Generic name
Suction cannula, reusable
Device name
Suction/Irrigation HiQ - tube
Model / Ref / Catalog
WA51131A
Primary DI / UDI-DI
04042761024303
Basic UDI-DI
4042761110274Y
Direct marketing DI
04042761024303
510(k) Number
FDA product code
GCJ
EMDN code
L1299 Laparoscopic and thoracoscopic instruments, reusable - other
GMDN term
Suction cannula, reusable
Device class
Class IIa 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 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: Suction cannula, reusable

Cleared under the same submission (K923982)

and 8 more cleared under K923982

Similar devices in this category

Other devices filed under LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER.

Other devices from Olympus Winter & Ibe GmbH

  • Oes Elite WA2C2ASB

    Class II

  • Oes Elite WA2C21LO

    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)