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Olympus WA60101C

by Olympus Winter & Ibe GmbH

Ref WA60101C

Olympus WA60101C 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 12 Oct 2026 (Basic UDI-DI B-04042761062381), cleared under FDA 510(k) K984417 on 24 Feb 1999 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761062381), active as of 24 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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K984417

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761062381 Basic UDI-DI 04042761062381UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761062381 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK984417 Date24 Feb 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761062381 registered 12 Oct 2026 Active
  • FDA 510(k) K984417 decided 24 Feb 1999 Active
  • FDA GUDID UDI-DI 04042761062381 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K984417
  2. Listed FDA GUDID 04042761062381
  3. Registered EUDAMED B-04042761062381

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  • Withdrawn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+", Ergo, bipolar EUDAMED
Olympus GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
WA60101C
Primary DI / UDI-DI
04042761062381
Basic UDI-DI
B-04042761062381
510(k) Number
FDA product code
GEI
EMDN code
L180302 Endoscopic electrosurgery handpieces, reusable
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
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 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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K984417)

and 6 more cleared under K984417

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE.

Other devices from Olympus Winter & Ibe GmbH

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    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)