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Olympus A70958A

by Olympus Winter & Ibe GmbH

Ref A70958A

Olympus A70958A is a device classified as Class I 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-04042761010603), cleared under FDA 510(k) K951354 on 14 Jun 1995 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761010603), 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) K951354

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-04042761010603 Basic UDI-DI 04042761010603UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761010603 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK951354 Date14 Jun 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761010603 registered 5 Nov 2026 Active
  • FDA 510(k) K951354 decided 14 Jun 1995 Active
  • FDA GUDID UDI-DI 04042761010603 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K951354
  2. Listed FDA GUDID 04042761010603
  3. Registered EUDAMED B-04042761010603

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  • Withdrawn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
Endoscopic surgical probe
Model / Ref / Catalog
A70958A
Primary DI / UDI-DI
04042761010603
Basic UDI-DI
B-04042761010603
FDA product code
HRX
EMDN code
Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories
GMDN term
Endoscopic surgical probe
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.1100
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Endoscopic surgical probe

Cleared under the same submission (K951354)

and 8 more cleared under K951354

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)