Uresil Valve Cutter with Interchangeable Heads
FDA 510(k)Class II (US FDA 510(k))
by Uresil Corp.
Identifiers
- 510(k) Number
- K930011 FDA 510(k)
- FDA Product Code
- MGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4885 FDA 510(k)
- Regulation Number
- 870.4885 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Uresil Valve Cutter with Interchangeable Heads is a valvulotome, a Class II medical device intended for use in cardiovascular procedures. It is designed to cut or trim heart valves and is supplied with interchangeable heads to accommodate different anatomical requirements. The device is classified under regulation number 870.4885 and falls within the Cardiovascular medical specialty.
This single-use device is supplied sterile and is intended for one-time clinical application. It is not evaluated for MRI safety and should not be used in MRI environments. The device is stored in a dry, controlled environment and is authorized for distribution in the United States under FDA 510(k) clearance. It is manufactured by Uresil Corp. and is available in configurations that include interchangeable heads for procedural flexibility.
Frequently asked questions
What is the Uresil Valve Cutter used for?
It is a valvulotome used in cardiovascular procedures to cut or trim heart valves. The interchangeable heads allow the device to adapt to different anatomical requirements during surgery.
How is the device supplied?
The Uresil Valve Cutter is supplied sterile and is intended for single use. It is packaged to maintain sterility until opened and is stored in a dry, controlled environment.
Can it be reused or resterilized?
No, this is a single-use device. It is designed for one-time clinical application and must be discarded after use. Reuse or resterilization is not supported by the manufacturer.
Is it safe to use in an MRI environment?
No, the device has not been evaluated for MRI safety and should not be used in MRI environments. It is not compatible with magnetic resonance imaging systems.
What regulatory clearance does it have?
The Uresil Valve Cutter with Interchangeable Heads is authorized under FDA 510(k) clearance as a Class II device. It is classified under regulation number 870.4885 and is substantially equivalent to existing devices in the cardiovascular specialty.
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: FDA Browser - Cleared 510 (K) - URESIL VALVE CUTTER WITH ..., Uresil Valve Cutter With Interchangeable Heads, PDF K930011 - Uresil Valve Cutter With Interchangeable Heads, K905528 FDA 510 (k) - URESIL VALVE CUTTER | Uresil Corp., URESIL VALVE CUTTER (K905528) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K930011 | Class II | Active |
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Manufacturer
- Manufacturer
- Uresil Corp.
Sources (1)
- FDA 510(k) K930011 24 fields · synced Sep 24, 2026