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Olympus A64810S

by Olympus Winter & Ibe GmbH

Ref A64810S

Olympus A64810S is a device classified as Class IIa in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04042761029995), cleared under FDA 510(k) K944200 on 15 Sep 1995 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761029995), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944200

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761029995 Basic UDI-DI 04042761029995UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761029995 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944200 Date15 Sep 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761029995 registered 5 Oct 2026 Active
  • FDA 510(k) K944200 decided 15 Sep 1995 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761029995 listed 21 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K944201
  2. Cleared FDA 510(k) K944200
  3. Listed FDA GUDID 04042761029995
  4. Registered EUDAMED B-04042761029995

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  • Withdrawn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
Jaws "HiQ+", 5 x 250 mm, scissors, Metzenbaum EUDAMED
Olympus GUDID
Generic name
Rigid endoscopic scissors, reusable
Model / Ref / Catalog
A64810S
Primary DI / UDI-DI
04042761029995
Basic UDI-DI
B-04042761029995
510(k) Number
FDA product code
GCJ, HET
EMDN code
L180202 Endoscopic electrosurgery scissors, reusable
GMDN term
Rigid endoscopic scissors, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500, 884.1720
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Rigid endoscopic scissors, reusable

Cleared under the same submission (K944200)

and 8 more cleared under K944200

Cleared under the same submission (K944201)

and 8 more cleared under K944201

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY SCISSORS, REUSABLE.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)