Identity
- Trade Name
- mini OTSC System Set FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • 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
- 10/3 a FDA UDI
- Description
- The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • 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
- 100.01 FDA UDI
- Primary DI / UDI-DI
- 04260206311102 FDA UDI
- 510(k) Number
- K101428 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
No
FDA UDI
MR Conditional FDA UDI
Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
mini OTSC System 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
Cleared under the same submission
K101428 also covers:
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
- OTSC System Set — Ovesco Endoscopy AG
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 ee72b990-2d51-4b11-a581-79f9a1a4c927 37 fields · synced Jun 8, 2026