OTSCneo System Set (100.03n-14n, 100.27n-31n)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251562 FDA 510(k)
- FDA Product Code
- PKL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4400 FDA 510(k)
- Regulation Number
- 876.4400 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OTSCneo System Set is a hemostatic metal clip for the gastrointestinal tract designed for flexible endoscopy. It functions as an over-the-scope clip application device used for the treatment of gastrointestinal hemorrhage and the closure of acute and chronic wall lesions.
The system components include a memory-shape alloy clip mounted on a transparent plastic cap, a hand wheel, and a thread retriever. This device is regulated as a Class II medical device under FDA 510(k) clearance K251562.
Frequently asked questions
What is the primary clinical use of the OTSCneo System Set?
The OTSCneo System Set is indicated for use in the gastrointestinal tract during flexible endoscopy. It is specifically designed to treat gastrointestinal hemorrhage and to facilitate the closure of both acute and chronic wall lesions.
What components are included in the OTSCneo System Set?
The system is a comprehensive set that includes a memory-shape alloy clip mounted on a transparent plastic cap, a hand wheel for operation, and a thread retriever to assist with the application process.
What is the regulatory status of this device?
The OTSCneo System Set is regulated as a Class II medical device. It has received FDA 510(k) clearance under the number K251562, confirming it is substantially equivalent to legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ovesco Endoscopy AG - OTSC®neo System Set, Ovesco Endoscopy AG - OTSC®neo System, OTSCneo System Set (100.03n-14n, 100.27n-31n), K251562 FDA 510(k) - OTSCneo System Set (100.03n-14n
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251562 | Class II | Active |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy Ag
Sources (1)
- FDA 510(k) K251562 24 fields · synced Sep 23, 2026