Skip to content

stentfix OTSC System Set

by Ovesco Endoscopy AG

Ref 100.50Model stentfix OTSC System Set

stentfix OTSC System Set (100.50) is a device classified as Class IIb in the EU and Class II in the US made by Ovesco Endoscopy AG, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 426020631OTSC0037K) with CE/MDR certificate 1000317372 valid until 16 Nov 2030, cleared under FDA 510(k) K183309 on 22 Oct 2019 and listed in FDA GUDID since 23 Sep 2020 (UDI-DI 04260206311287), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

16 Nov 2030

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K183309

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/MDR EUDAMED Number426020631OTSC0037K Basic UDI-DI 04260206311287UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260206311287 UDI-DI Date23 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183309 Date22 Oct 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426020631OTSC0037K registered 28 Sep 2026 Active· +1 more in the status table
  • FDA 510(k) K183309 decided 22 Oct 2019 Active
  • FDA GUDID UDI-DI 04260206311287 listed 23 Sep 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000317372 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    16 Nov 2030
    Reason
    Change approved

Timeline

5 dated events

  1. Cleared FDA 510(k) K183309
  2. Listed FDA GUDID 04260206311287
  3. Certificate issued EUDAMED 1000317372
  4. Registered EUDAMED 426020631OTSC0037K
  5. Certificate expires EUDAMED 1000317372

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  • Withdrawn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

Generic name
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Model / Ref / Catalog
stentfix OTSC System Set, 100.50, stentfix
Primary DI / UDI-DI
04260206311287
Basic UDI-DI
426020631OTSC0037K
Direct marketing DI
04260206311287
510(k) Number
FDA product code
PKL, OCZ
EMDN code
G030202 Digestive endoscopy, haemostasis clips
GMDN term
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4400, 876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
stentfix OTSC System Set
100.50
GUDID
stentfix
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

Cleared under the same submission (K183309)

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS.

Other devices from Ovesco Endoscopy AG

See all devices from Ovesco Endoscopy AG →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)