Olympus WA2UR11A

by Olympus Winter & Ibe GmbH

Olympus WA2UR11A is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K200369 on 28 Aug 2020 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 04042761086387), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04042761086387 UDI-DI	Date15 Jul 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200369	Date28 Aug 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04042761086387
FDA 510(k) database 510(k) number K200369

Across registries

2 registries list this device

FDA 510(k) K200369 decided 28 Aug 2020 Active
FDA GUDID UDI-DI 04042761086387 listed 15 Jul 2021 Listed

Timeline

2 dated events

28 Aug 2020 Cleared FDA 510(k) K200369
15 Jul 2021 Listed FDA GUDID 04042761086387

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Olympus
Generic name: Rigid optical ureteroscope
Model / Ref / Catalog: WA2UR11A

Primary DI / UDI-DI: 04042761086387
FDA product code: FGB
GMDN term: Rigid optical ureteroscope

Device class: Class II
Regulation number: 876.1500
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (11, all answered No)