NeuWave Microwave Ablation System and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231738 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 is a microwave ablation device designed for the coagulation and ablation of soft tissue. It operates through microwave energy to create controlled thermal lesions, suitable for percutaneous, open surgical, and laparoscopic procedures, including the treatment of non-resectable liver tumors.
The system is supplied as a reusable medical device with FDA 510(k) clearance and MDR authorization, intended for use in clinical settings requiring precise ablation. It includes multiple accessory components (listed by FEI numbers) and is classified under regulation 878.4400. Sterility and MRI safety are not specified in the provided data, and usage is restricted to authorized medical professionals in accordance with regulatory guidelines.
Frequently asked questions
What is the primary purpose of the NEUWAVE Microwave Ablation System?
The system is designed for coagulation and ablation of soft tissue using microwave energy to create controlled thermal lesions, particularly for treating non-resectable liver tumors through percutaneous, open surgical, or laparoscopic procedures.
Is the NEUWAVE system a single-use or reusable device?
The NEUWAVE Microwave Ablation System is supplied as a reusable medical device intended for use in clinical settings requiring precise ablation procedures.
What accessories are included with the NEUWAVE system?
The system includes multiple accessory components identified by various FEI numbers, though specific accessory details beyond the FEI numbers are not provided in the available data.
What regulatory approvals does the NEUWAVE system have?
The system has FDA 510(k) clearance and MDR authorization, classified under regulation 878.4400, and is intended for use by authorized medical professionals in accordance with regulatory guidelines.
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: Products | NeuWave Microwave Ablation | NeuWave Medical, Inc., NeuWave System | NeuWave Microwave Ablation | NeuWave Medical, Inc., NeuWave Microwave Ablation | Quantum Surgical, Neuwave Medical, Inc. FDA 510 (k) Products - Latest 2024
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 | K231738 | Class II | Active |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
Sources (2)
- FDA 510(k) K231738 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026