NeuWave Microwave Ablation System and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220472 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 microwave ablation device designed for tissue ablation procedures. It employs microwave energy to heat and destroy targeted tissue, commonly used in surgical interventions such as tumor removal or tissue resection. This system falls under the classification of a microwave ablation device, intended for controlled thermal ablation in clinical settings.
The system is supplied as a reusable medical device, with associated single-use or reusable accessories depending on the specific components. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), adhering to strict safety and performance standards. The device operates in controlled environments such as operating rooms or outpatient surgical facilities, with compatibility for use in non-MRI environments. Multiple accessory models are included, each identified by unique reference codes for precise application.
Frequently asked questions
What types of surgical procedures is the NeuWave Microwave Ablation System primarily used for?
The NeuWave Microwave Ablation System is designed for controlled thermal ablation procedures, commonly used in tumor removal or tissue resection. Its microwave energy allows precise targeting of tissue destruction, making it suitable for interventions in fields like general and plastic surgery where localized ablation is required.
Is the NeuWave Microwave Ablation System itself reusable, or are its accessories single-use?
The NeuWave Microwave Ablation System itself is a reusable medical device, but its accessories vary by component—some are single-use while others are reusable. This design flexibility ensures compatibility with different clinical workflows and sterility requirements.
How many accessory models are included with the NeuWave Microwave Ablation System, and how are they identified?
The system includes multiple accessory models, each uniquely identified by specific reference codes (e.g., 1000523114, 1721676, etc.). These codes help clinicians select the correct accessory for precise application during ablation procedures.
Where can the NeuWave Microwave Ablation System be used, and what environmental considerations apply?
The system is intended for use in controlled surgical environments like operating rooms or outpatient facilities. It is explicitly designed for non-MRI environments, meaning it should not be used in areas with magnetic resonance imaging equipment.
What regulatory pathways does the NeuWave Microwave Ablation System follow, and how does this affect its use?
The system follows FDA 510(k) clearance and EU Medical Device Regulation (MDR) compliance, ensuring it meets strict safety and performance standards. These regulatory pathways confirm its suitability for clinical use in the U.S. and EU markets, respectively, but do not dictate its clinical indications—those are determined by medical professionals based on procedural needs.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220472 | Class II | Active |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
Sources (2)
- FDA 510(k) K220472 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026