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Olympus WA60120A

by Olympus Winter & Ibe GmbH

Ref WA60120A

Olympus WA60120A 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 5 Oct 2026 (Basic UDI-DI B-04042761031066), cleared under FDA 510(k) K923982 on 15 Mar 1993 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761031066), active as of 25 Oct 2026.

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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K923982

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761031066 Basic UDI-DI 04042761031066UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761031066 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 B-04042761031066 registered 5 Oct 2026 Active
  • FDA 510(k) K923982 decided 15 Mar 1993 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761031066 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

5 dated events

  1. Cleared FDA 510(k) K912362
  2. Cleared FDA 510(k) K923982
  3. Recall initiated FDA recalls Z-1163-2010
  4. Listed FDA GUDID 04042761031066
  5. Registered EUDAMED B-04042761031066

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  • Withdrawn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
Handle "HiQ+", inline A, asymmetric, ratchet EUDAMED
Olympus GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
WA60120A
Primary DI / UDI-DI
04042761031066
Basic UDI-DI
B-04042761031066
FDA product code
EWY, GCJ
EMDN code
L1205 Laparoscopic and thoracoscopic surgery needle holders, reusable
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4720, 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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K912362)

and 7 more cleared under K912362

Cleared under the same submission (K923982)

and 8 more cleared under K923982

Similar devices in this category

Other devices filed under LAPAROSCOPIC AND THORACOSCOPIC SURGERY NEEDLE HOLDERS, REUSABLE.

Other devices from Olympus Winter & Ibe GmbH

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    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)