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Clip HX-610-090

by Olympus Medical Systems Corporation

Ref N6012330

Clip HX-610-090 (N6012330) is a device classified as Class IIa in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04953170415111), cleared under FDA 510(k) K240617 on 3 Jun 2024 and listed in FDA GUDID since 9 Oct 2019 (UDI-DI 04953170415111), 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) K240617

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170415111 Basic UDI-DI 04953170415111UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240617 Date3 Jun 2024DecidedStatusActive
United StatesGUDID listing GUDID Number04953170415111 UDI-DI Date9 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04953170415111 registered 5 Oct 2026 Active
  • FDA 510(k) K240617 decided 3 Jun 2024 Active
  • FDA GUDID UDI-DI 04953170415111 listed 9 Oct 2019 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 04953170415111
  2. Cleared FDA 510(k) K240617
  3. Registered EUDAMED B-04953170415111

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  • Withdrawn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
Clip, Long Clip, Short Clip, Colored Short Clip Hx-610-090 EUDAMED
Clip GUDID
Generic name
Ligation clip, metallic
Model / Ref / Catalog
N6012330, HX-610-090
Primary DI / UDI-DI
04953170415111
Basic UDI-DI
B-04953170415111
510(k) Number
FDA product code
PKL
EMDN code
G030202 Digestive endoscopy, haemostasis clips
GMDN term
Ligation clip, metallic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N6012330
GUDID
HX-610-090
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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: Ligation clip, metallic

Cleared under the same submission (K240617)

and 8 more cleared under K240617

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)