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Olympus A70951A

by Olympus Winter & Ibe GmbH

Olympus A70951A 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 04042761010573), 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) K951354

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 Number04042761010573 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951354 Date14 Jun 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951354 decided 14 Jun 1995 Active
  • FDA GUDID UDI-DI 04042761010573 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K951354
  2. Listed FDA GUDID 04042761010573

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  • Withdrawn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
Laparoscopic access cannula, reusable
Model / Ref / Catalog
A70951A
Primary DI / UDI-DI
04042761010573
FDA product code
HRX
GMDN term
Laparoscopic access cannula, 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
  • Lot / batch number
Other properties (12, all answered No)