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Olympus WA99516C

by Olympus Winter & Ibe GmbH

Ref WA99516C

Olympus WA99516C 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 2 Nov 2026 (Basic UDI-DI B-14042761085882), cleared under FDA 510(k) K173877 on 15 Feb 2018 and listed in FDA GUDID since 27 Jan 2023 (UDI-DI 14042761085882), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173877

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-14042761085882 Basic UDI-DI 14042761085882UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14042761085882 UDI-DI Date27 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173877 Date15 Feb 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-14042761085882 registered 2 Nov 2026 Active
  • FDA 510(k) K173877 decided 15 Feb 2018 Active
  • FDA GUDID UDI-DI 14042761085882 listed 27 Jan 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173877
  2. Listed FDA GUDID 14042761085882
  3. Registered EUDAMED B-14042761085882

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  • Withdrawn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
Neutral electrode, universal size, with cable EUDAMED
Olympus GUDID
Generic name
Electrosurgical return electrode, single-use
Model / Ref / Catalog
WA99516C
Primary DI / UDI-DI
14042761085882
Basic UDI-DI
B-14042761085882
510(k) Number
FDA product code
GEI
EMDN code
K02010201 Electrosurgery single patient pads (neutral electrodes), single-use
GMDN term
Electrosurgical return electrode, single-use
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

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: Electrosurgical return electrode, single-use

Cleared under the same submission (K173877)

and 2 more cleared under K173877

Similar devices in this category

Other devices filed under ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)