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OTSC System Set 12/6 t

by Ovesco Endoscopy AG

Part of a family of 38 devices: see the family page

Ref 100.12Model OTSC System Set

OTSC System Set 12/6 t (100.12) 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 4 Dec 2025 (Basic UDI-DI 426020631OTSC0017F) with CE/MDR certificate 1000317372 valid until 16 Nov 2030, cleared under FDA 510(k) K101428 on 1 Dec 2010 and listed in FDA GUDID since 18 Sep 2015 (UDI-DI 04260206310105), active as of 25 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 25 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K101428

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000317372 Date25 Sep 2026IssuedStatusActive expires 16 Nov 2030
United StatesGUDID listing GUDID Number04260206310105 UDI-DI Date18 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101428 Date1 Dec 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426020631OTSC0017F registered 4 Dec 2025 Active· +1 more in the status table
  • FDA 510(k) K101428 decided 1 Dec 2010 Active
  • FDA GUDID UDI-DI 04260206310105 listed 18 Sep 2015 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) K101428
  2. Listed FDA GUDID 04260206310105
  3. Registered EUDAMED 426020631OTSC0017F
  4. Certificate issued EUDAMED 1000317372
  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  • Withdrawn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

Trade name
OTSC System Set: 12/6 t EUDAMED
OTSC System Set GUDID
Generic name
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Model / Ref / Catalog
OTSC System Set, 100.12, 12/6 t
Primary DI / UDI-DI
04260206310105
Basic UDI-DI
426020631OTSC0017F
510(k) Number
FDA product code
PKL
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
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
OTSC System Set
100.12
GUDID
12/6 t
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 (K101428)

and 8 more cleared under K101428

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)