Identity
- Trade Name
- BARS Set FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant FDA UDI
- Model / Reference
- BARS Set FDA UDI
- Description
- The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant FDA UDI
Identifiers
- Catalog Number
- 100.60 FDA UDI
- Primary DI / UDI-DI
- 04260206310983 FDA UDI
- 510(k) Number
- K241858 FDA UDI
- FDA Product Code
- PKL 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 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
Dimensions & Sizes
- Size
- Balloon Length — 1800 Millimeter FDA UDIBalloon Diameter — 20 Millimeter FDA UDIBalloon Length — 1850 Millimeter FDA UDIBalloon Diameter — 6 Millimeter FDA UDIGuidewire Length — 3700 Millimeter FDA UDIGuidewire Diameter — 0.035 Inch FDA UDI
Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
BARS Set by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip, long-term, non-bioabsorbable.
- OTSC System Set — Ovesco Endoscopy USA · Class II
- OTSC System Set — Ovesco Endoscopy USA · Class II
- Instinct — COOK INCORPORATED · 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
- OTSC System Set — Ovesco Endoscopy USA · 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
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 AG
Sources (1)
- FDA UDI f52eb525-2137-4926-9e9c-0c3afc86d2b1 37 fields · synced Jun 6, 2026