Resposable Omni Tip Switchable Tips
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K964585 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Resposable Omni Tip Switchable Tips are laser fibers classified as accessories to laser-powered surgical instruments. These specialized devices are designed for use in portal vein interventions and allow for switching tips during procedures to provide flexibility and precision.
This device is supplied by Trimedyne, Inc. and has received FDA 510(k) clearance. It is categorized under the GEX product code for powered laser surgical instruments.
Frequently asked questions
What is the primary clinical application for the Resposable Omni Tip Switchable Tips?
These laser fibers are specifically designed for use in portal vein interventions. They function as accessories to laser-powered surgical instruments to assist in these procedures.
Why are these tips described as switchable?
The tips are designed to be switchable during surgical procedures to provide the clinician with increased flexibility and precision when using laser-powered instruments.
What is the regulatory status of the Resposable Omni Tip Switchable Tips?
This device has received FDA 510(k) clearance from the U.S. Food and Drug Administration. It is categorized under the GEX product code for powered laser surgical instruments.
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: Resposable Omni Tip (Tm) Switchable Tips (Multiple), K964585 FDA 510(k) - RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS..., resposable omni tip tm switchable tips multiple
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964585 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K964585 24 fields · synced Sep 26, 2026