Identity
- Trade Name
- stentfix OTSC System Set FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- The stentfix OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant FDA UDI
- Model / Reference
- stentfix FDA UDI
- Description
- The stentfix OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant FDA UDI
Identifiers
- Catalog Number
- 100.50 FDA UDI
- Primary DI / UDI-DI
- 04260206311706 FDA UDI
- 510(k) Number
- K183309 FDA UDI
- FDA Product Code
- PKL FDA UDIOCZ FDA UDI
- GMDN Term
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4400 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
stentfix OTSC System Set by Ovesco Endoscopy USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip, long-term, non-bioabsorbable.
- Instinct — COOK INCORPORATED · Class II
- S.T.A.R(TM) Disposable Hemostatic Closure Clip Device — Micro-Tech (Nanjing) Co., Ltd. · Class II
- OTSC System Set — Ovesco Endoscopy AG · Class II
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- OTSC System Set — Ovesco Endoscopy AG · Class II
- S.T.A.R(TM) Disposable Hemostatic Closure Clip Device — Micro-Tech (Nanjing) Co., Ltd. · Class II
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- Medeon — Medeon Biodesign, Inc. · Class I
Cleared under the same submission
K183309 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy USA
Sources (1)
- FDA UDI 9b4258c8-9d5e-4acb-a082-bf8c90b4e9c9 37 fields · synced May 30, 2026