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Foot holder MAJ-2431

by Olympus Medical Systems Corporation

Ref N6013700

Foot holder MAJ-2431 (N6013700) is a device classified as Class I in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 495317000104B4), cleared under FDA 510(k) K222861 on 15 Jun 2023 (1 earlier submission) and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04953170415654), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222861

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000104B4 Basic UDI-DI 04953170415654UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170415654 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222861 Date15 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000104B4 registered 23 Oct 2026 Active
  • FDA 510(k) K222861 decided 15 Jun 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04953170415654 listed 4 Jul 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0181-2025 FDA Class II initiated 21 Aug 2024

    It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

Timeline

5 dated events

  1. Cleared FDA 510(k) K222584
  2. Cleared FDA 510(k) K222861
  3. Listed FDA GUDID 04953170415654
  4. Recall initiated FDA recalls Z-0181-2025
  5. Registered EUDAMED 495317000104B4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Foot Holder MAJ-2431 EUDAMED
Foot holder GUDID
Generic name
Surgical instrument assist arm system, manually-adjusted
Device name
Foot Holder_Instruments For The Acquisition And Management Of Endoscopic And Minimally Invasive Surgery Images
Model / Ref / Catalog
N6013700, MAJ-2431
Primary DI / UDI-DI
04953170415654
Basic UDI-DI
495317000104B4
510(k) Number
FDA product code
EOQ, EOB, FDF, FDS, NWB, FET, NTN
EMDN code
Z12020480 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories
GMDN term
Surgical instrument assist arm system, manually-adjusted
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680, 874.4760, 876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N6013700
GUDID
MAJ-2431
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: Surgical instrument assist arm system, manually-adjusted

Cleared under the same submission (K222584)

and 3 more cleared under K222584

Cleared under the same submission (K222861)

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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