NeuWave Microwave Ablation System and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200081 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 NeuWave Microwave Ablation System and Accessories is a medical device used for microwave ablation procedures. It is designed to deliver microwave energy to ablate or destroy targeted tissue in the body. The system includes various accessories that facilitate the ablation process.
This device is supplied as a system with accessories and is intended for single-use or reusable as specified by the manufacturer. It is not MRI safe and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with the product code NEY and is classified as a class II device.
Frequently asked questions
What is the NeuWave Microwave Ablation System used for?
The NeuWave Microwave Ablation System is designed to deliver microwave energy to ablate or destroy targeted tissue in the body during medical procedures. It includes various accessories to facilitate the ablation process.
Is the NeuWave Microwave Ablation System single-use or reusable?
The NeuWave Microwave Ablation System can be supplied for either single-use or reusable purposes as specified by the manufacturer. The specific usage instructions would be provided with the product.
What is the regulatory status of the NeuWave Microwave Ablation System?
The NeuWave Microwave Ablation System has received FDA 510(k) clearance with the product code NEY and is classified as a class II device. It is not MRI safe and should be stored according to the manufacturer's instructions.
What accessories are included with the NeuWave Microwave Ablation System?
The NeuWave Microwave Ablation System is supplied as a complete system with various accessories that facilitate the ablation process. The specific accessories included would depend on the particular configuration purchased.
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 | K200081 | Class II | Active |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
Sources (1)
- FDA 510(k) K200081 24 fields · synced Oct 6, 2026