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Olympus WA33036A

by Olympus Winter & Ibe GmbH

Olympus WA33036A is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K853486 on 12 Sep 1985 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761051866), 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

510(k) K853486

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04042761051866 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK853486 Date12 Sep 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K853486 decided 12 Sep 1985 Active
  • FDA GUDID UDI-DI 04042761051866 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K853486
  2. Listed FDA GUDID 04042761051866

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Olympus
Generic name
Rigid optical nephroscope
Model / Ref / Catalog
WA33036A
Primary DI / UDI-DI
04042761051866
FDA product code
FGA
GMDN term
Rigid optical nephroscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid optical nephroscope

Cleared under the same submission (K853486)

and 8 more cleared under K853486

Similar devices

Other devices filed under FDA product code FGA (Kit, Nephroscope).

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 (12, all answered No)