Identifiers
- 510(k) Number
- K062057 FDA 510(k)
- FDA Product Code
- FZP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The U-Clip Device, Model NC65 is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. It consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon.
The device is manufactured by Medtronic Vascular and is classified as an implantable clip under product code FZP with Class II special controls. It received FDA 510(k) clearance on August 2, 2006, and is intended for use in general and plastic surgery procedures.
Frequently asked questions
What is the U-Clip Device NC65 used for?
The U-Clip Device NC65 is a self-closing Nitinol clip designed for anastomosis and tissue and prosthetic material approximation or attachment applications in general and plastic surgery procedures.
How is the U-Clip Device NC65 supplied and is it single-use?
The device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon. The description does not specify whether it is single-use or reusable.
What is the regulatory status of the U-Clip Device NC65?
The U-Clip Device NC65 is classified as an implantable clip under product code FZP with Class II special controls. It received FDA 510(k) clearance on August 2, 2006, and is manufactured by Medtronic Vascular.
What are the components of the U-Clip Device NC65?
The device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon during surgical procedures.
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: U-CLIP DEVICE, MODEL NC65 (K062057) — FDA 510(k) | Innolitics, K062057 - U-CLIP DEVICE | FDA 510 (k) | Medtronic Vascular, PDF 510(k) SUMMARY of Safety and Effectiveness
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062057 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K062057 24 fields · synced Oct 6, 2026