Olympus A70941A

by Olympus Winter & Ibe GmbH

Olympus A70941A is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K951354 on 14 Jun 1995 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761010542), 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	Number04042761010542 UDI-DI	Date21 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK951354	Date14 Jun 1995Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04042761010542
FDA 510(k) database 510(k) number K951354

Across registries

2 registries list this device

FDA 510(k) K951354 decided 14 Jun 1995 Active
FDA GUDID UDI-DI 04042761010542 listed 21 Sep 2016 Listed

Timeline

2 dated events

14 Jun 1995 Cleared FDA 510(k) K951354
21 Sep 2016 Listed FDA GUDID 04042761010542

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Olympus
Generic name: Rigid optical arthroscope, reusable
Model / Ref / Catalog: A70941A

Primary DI / UDI-DI: 04042761010542
FDA product code: HRX
GMDN term: Rigid optical arthroscope, reusable

Device class: Class II
Regulation number: 888.1100
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

Other properties (12, all answered No)