Solero Microwave Tissue Ablation (MTA) System and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223581 FDA 510(k)
- FDA Product Code
- NEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Solero Microwave Tissue Ablation (MTA) System and Accessories is a medical device designed for tissue ablation procedures. It operates by using microwave energy to generate heat, which destroys targeted tissue. The system includes accessories to support its use in clinical settings.
The device is supplied as a single-use system and is intended for use by trained healthcare professionals. It is not reusable and must be disposed of after use. The system is not MRI safe and requires proper storage in a controlled environment. The device has received FDA 510(k) authorization for its intended use.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223581 | Class II | Active |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA 510(k) K223581 24 fields · synced Sep 21, 2026