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Olympus WA47777A

by Olympus Winter & Ibe GmbH

Ref WA47777A

Olympus WA47777A is a rigid optical hysteroscope (EU MDD Class IIa; FDA Class II; FDA product code HIH, Hysteroscope (And Accessories)) made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-04042761085915), cleared under FDA 510(k) K213207 on 22 Dec 2021 and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 04042761085915), 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) K213207

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-04042761085915 Basic UDI-DI 04042761085915UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761085915 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213207 Date22 Dec 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761085915 registered 5 Nov 2026 Active
  • FDA 510(k) K213207 decided 22 Dec 2021 Active
  • FDA GUDID UDI-DI 04042761085915 listed 20 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213207
  2. Listed FDA GUDID 04042761085915
  3. Registered EUDAMED B-04042761085915

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  • Withdrawn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
Olympus
Generic name
Rigid optical hysteroscope
Device name
Sheath, 5.25 mm, 5 Fr. channel
Model / reference
WA47777A
Primary DI / UDI-DI
04042761085915
Basic UDI-DI
B-04042761085915
510(k) Number
FDA product code
HIH
EMDN code
Z12020799 Genitourinary endoscopy instruments – other
GMDN term
Rigid optical hysteroscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690
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 hysteroscope

Cleared under the same submission (K213207)

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)