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Y/C Cable MH-985

by Olympus Medical Systems Corporation

Part of a family of 54 devices: see the family page

Ref 4937900

Y/C Cable MH-985 (4937900) 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 495317000153BH), cleared under FDA 510(k) K222861 on 15 Jun 2023 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170028311), 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 Number495317000153BH Basic UDI-DI 04953170028311UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222861 Date15 Jun 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04953170028311 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000153BH registered 23 Oct 2026 Active
  • FDA 510(k) K222861 decided 15 Jun 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04953170028311 listed 21 Sep 2016 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. Listed FDA GUDID 04953170028311
  2. Cleared FDA 510(k) K222584
  3. Cleared FDA 510(k) K222861
  4. Recall initiated FDA recalls Z-0181-2025
  5. Registered EUDAMED 495317000153BH

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  • Withdrawn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
Y/C Video Cable Mh-985 EUDAMED
Y/C Cable GUDID
Generic name
Electrical-only medical device connection cable, reusable
Device name
Electrical-Only Medical Device Connection Cable, Reusable
Model / Ref / Catalog
4937900, MH-985
Primary DI / UDI-DI
04953170028311
Basic UDI-DI
495317000153BH
510(k) Number
FDA product code
EOB, EOQ, FDF, FDS, NWB, FET, NTN
EMDN code
Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4760, 874.4680, 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
4937900
GUDID
MH-985
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: Electrical-only medical device connection cable, reusable

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 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE 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)