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Olympus WA91301W

by Olympus Winter & Ibe GmbH

Ref WA91301W

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4042761110194Z Basic UDI-DI 04042761085946UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761085946 UDI-DI Date27 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1640-2026 FDA Class II initiated 25 Feb 2026

    Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

    • Ongoing Z-2339-2025 FDA Class II initiated 25 Jul 2025

    Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

    • Ongoing Z-2415-2024 FDA Class II initiated 21 Jun 2024

    Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

    • Ongoing Z-1167-2024 FDA Class II initiated 15 Dec 2023

    The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Foot switch double pedal EUDAMED
Olympus GUDID
Generic Name
Foot-switch, electrical
Device Name
Footswitches - wired
Model / Ref / Catalog
WA91301W
Primary DI / UDI-DI
04042761085946
Basic UDI-DI
4042761110194Z
510(k) Number
FDA Product Code
GEI
EMDN Code
Z12010905 Radiosurgical units
GMDN Term
Foot-switch, electrical
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K203277)

Other devices from Olympus Winter & Ibe GmbH

See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No