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Olympus WA4KS446

by Olympus Winter & Ibe GmbH

Ref WA4KS446

Olympus WA4KS446 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 10 Sep 2026 (Basic UDI-DI B-04042761083072), cleared under FDA 510(k) K153009 on 5 Apr 2016 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761083072), 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) K153009

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-04042761083072 Basic UDI-DI 04042761083072UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761083072 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153009 Date5 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761083072 registered 10 Sep 2026 Active
  • FDA 510(k) K153009 decided 5 Apr 2016 Active
  • FDA GUDID UDI-DI 04042761083072 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153009
  2. Listed FDA GUDID 04042761083072
  3. Registered EUDAMED B-04042761083072

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  • Withdrawn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, 4 mm, 45° inverse ULTRA EUDAMED
Olympus GUDID
Generic name
Rigid optical rhinoscope
Model / Ref / Catalog
WA4KS446
Primary DI / UDI-DI
04042761083072
Basic UDI-DI
B-04042761083072
FDA product code
EOB
EMDN code
Z12021008 Rhinoscopes
GMDN term
Rigid optical rhinoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4760
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 rhinoscope

Cleared under the same submission (K153009)

and 2 more cleared under K153009

Similar devices in this category

Other devices filed under ENT ENDOSCOPY INSTRUMENTS.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)