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Olympus WA64710A

by Olympus Winter & Ibe GmbH

Ref WA64710A

Olympus WA64710A 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-04042761031073), cleared under FDA 510(k) K923982 on 15 Mar 1993 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761031073), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761031073 Basic UDI-DI 04042761031073UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761031073 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-04042761031073 registered 5 Oct 2026 Active
  • FDA 510(k) K923982 decided 15 Mar 1993 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761031073 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 04042761031073
  5. Registered EUDAMED B-04042761031073

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  • Withdrawn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
Jaws "HiQ+", 5 x 330 mm, needle holder, left EUDAMED
Olympus GUDID
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
WA64710A
Primary DI / UDI-DI
04042761031073
Basic UDI-DI
B-04042761031073
FDA product code
EWY, GCJ
EMDN code
L1205 Laparoscopic and thoracoscopic surgery needle holders, reusable
GMDN term
Suturing needle holder, reusable
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: 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)