Skip to content

Olympus WA4KL100

by Olympus Winter & Ibe GmbH

Ref WA4KL100

Olympus WA4KL100 is a rigid optical laparoscope (EU MDD Class IIa; FDA Class II) made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-04042761082846), cleared under FDA 510(k) K150633 on 29 Apr 2015 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761082846), 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) K150633

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-04042761082846 Basic UDI-DI 04042761082846UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761082846 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150633 Date29 Apr 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761082846 registered 2 Nov 2026 Active
  • FDA 510(k) K150633 decided 29 Apr 2015 Active
  • FDA GUDID UDI-DI 04042761082846 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150633
  2. Listed FDA GUDID 04042761082846
  3. Registered EUDAMED B-04042761082846

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  • Withdrawn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
Telescope 10 mm, 0° ULTRA EUDAMED
Olympus GUDID
Generic name
Rigid optical laparoscope
Model / Ref / Catalog
WA4KL100
Primary DI / UDI-DI
04042761082846
Basic UDI-DI
B-04042761082846
FDA product code
HET, NMH, GCJ
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1720, 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: Rigid optical laparoscope

Cleared under the same submission (K150633)

and 1 more cleared under K150633

Similar devices in this category

Other devices filed under LAPAROSCOPES.

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
  • Serial number
Other properties (22, all answered No)