Skip to content

Olympus WA56900A

by Olympus Winter & Ibe GmbH

Ref WA56900A

Olympus WA56900A is a device classified as Class I in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-04042761052801), cleared under FDA 510(k) K923982 on 15 Mar 1993 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04042761052801), 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-04042761052801 Basic UDI-DI 04042761052801UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761052801 UDI-DI Date22 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-04042761052801 registered 12 Oct 2026 Active
  • FDA 510(k) K923982 decided 15 Mar 1993 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761052801 listed 22 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 04042761052801
  5. Registered EUDAMED B-04042761052801

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  • Withdrawn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
Grasping forceps, needle holder, 5 x 300 mm, inline handle, with self-alignment EUDAMED
Olympus GUDID
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
WA56900A
Primary DI / UDI-DI
04042761052801
Basic UDI-DI
B-04042761052801
FDA product code
GCJ, EWY
EMDN code
L1205 Laparoscopic and thoracoscopic surgery needle holders, reusable
GMDN term
Suturing needle holder, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 874.4720
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Suturing needle holder, reusable

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

  • 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)