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Olympus WA33028A

by Olympus Winter & Ibe GmbH

Ref WA33028A

Olympus WA33028A 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 5 Nov 2026 (Basic UDI-DI B-04042761062664), cleared under FDA 510(k) K853486 on 12 Sep 1985 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761062664), 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) K853486

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-04042761062664 Basic UDI-DI 04042761062664UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761062664 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK853486 Date12 Sep 1985DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761062664 registered 5 Nov 2026 Active
  • FDA 510(k) K853486 decided 12 Sep 1985 Active
  • FDA GUDID UDI-DI 04042761062664 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K853486
  2. Listed FDA GUDID 04042761062664
  3. Registered EUDAMED B-04042761062664

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  • Withdrawn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
Endoscope sheath, reusable
Model / Ref / Catalog
WA33028A
Primary DI / UDI-DI
04042761062664
Basic UDI-DI
B-04042761062664
510(k) Number
FDA product code
FGA
EMDN code
U040201 Nephrostomy kits, direct puncture
GMDN term
Endoscope sheath, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
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: Endoscope sheath, reusable

Cleared under the same submission (K853486)

and 8 more cleared under K853486

Similar devices in this category

Other devices filed under NEPHROSTOMY KITS, DIRECT PUNCTURE.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)