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Docking fixture MAJ-1876

by Olympus Medical Systems Corporation

Ref N3809630

Docking fixture MAJ-1876 (N3809630) 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 495317000156BP), cleared under FDA 510(k) K111202 on 20 Jan 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170308499), active as of 7 Nov 2026. 10 FDA recalls are 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

9 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111202

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/MDR EUDAMED Number495317000156BP Basic UDI-DI 04953170308499UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170308499 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111202 Date20 Jan 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000156BP registered 23 Oct 2026 Active
  • FDA 510(k) K111202 decided 20 Jan 2012 Active
  • FDA GUDID UDI-DI 04953170308499 listed 21 Sep 2016 Listed

Recalls

10 recalls · 9 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-1375-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1382-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1377-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1378-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1376-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1381-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1374-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1380-2026 FDA Class II initiated 22 Oct 2025
    • Ongoing Z-1379-2026 FDA Class II initiated 22 Oct 2025

    Firm is initiating a removal due to continued reports of adverse events.

    • Terminated Z-0432-2014 FDA Class II initiated 27 Sep 2013

    Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-1375-2026
  2. Recall initiated FDA recalls Z-1382-2026
  3. Recall initiated FDA recalls Z-1377-2026
  4. Recall initiated FDA recalls Z-1378-2026
  5. Recall initiated FDA recalls Z-1376-2026
  6. Recall initiated FDA recalls Z-1381-2026
  7. Recall initiated FDA recalls Z-1374-2026
  8. Recall initiated FDA recalls Z-1380-2026
  9. Recall initiated FDA recalls Z-1379-2026
  10. Registered EUDAMED 495317000156BP

3 earlier events are in the sections above.

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
Docking fixture MAJ-1876 EUDAMED
Docking fixture GUDID
Generic name
Portable active medical device mount
Device name
Accessory_Portable Active Medical Device Mount
Model / Ref / Catalog
N3809630, MAJ-1876
Primary DI / UDI-DI
04953170308499
Basic UDI-DI
495317000156BP
FDA product code
KNS, GEI, LFL
EMDN code
Z12010880, Z12010980
GMDN term
Portable active medical device mount
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.4300, 878.4400
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
N3809630
GUDID
MAJ-1876
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: Portable active medical device mount

Cleared under the same submission (K111202)

and 8 more cleared under K111202

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY - 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)