Ablation systems
NeuWave
A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device.
NeuWave models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 2.45 GHz Ablation System | — | MR Unsafe | Available |
| CSURG | — | MR Unsafe | Available |
| DR-000770 | — | MR Unsafe | Available |
| DR-000894 | — | MR Unsafe | Available |
| FLEX4 | Outer Diameter 2 mm; Length 150 cm | MR Unsafe | Available |
| FLEX6 | Length 150 cm; Outer Diameter 2 mm | MR Unsafe | Available |
| FSWITCH1 | — | MR Unsafe | Available |
| FSWITCH2 | — | MR Unsafe | Available |
| LK15XT | Length 15 cm | MR Unsafe | Available |
| LK20 | Length 20 cm | MR Unsafe | Available |
| LK20XT | Length 20 cm | MR Unsafe | Available |
| NWA1US1N | — | MR Unsafe | Available |
| NWC1US1N | — | MR Unsafe | Available |
| NWC1US1R | — | MR Unsafe | Available |
| NWF1US1N | — | MR Unsafe | Available |
| NWF2CN1N | — | MR Unsafe | Available |
| NWF2HK1N | — | MR Unsafe | Available |
| NWF2SG1N | — | MR Unsafe | Available |
| NWSR25 | Length 25 cm | MR Unsafe | Available |
| PR15XT | Length 15 cm | MR Unsafe | Available |
| PR20XT | Length 20 cm | MR Unsafe | Available |
| PRS15 | Length 15 cm | MR Unsafe | Available |
| PRS35 | Length 35 cm | MR Unsafe | Available |
| PRSURGKT | — | MR Unsafe | Available |
| RC17PK | — | MR Unsafe | Available |
| RCPK | — | MR Unsafe | Available |
FDA clearances
- 510(k) K231738 November 2023
- 510(k) K200081 November 2020
- 510(k) K163118 March 2017
Procedures that use ablation systems
Frequently asked questions
What is NeuWave used for?
A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device.
Who makes NeuWave?
NeuWave is made by NeuWave Medical, Inc.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does NeuWave come in?
Sizes listed for NeuWave: Length: 15–150 cm; Outer Diameter: 2 mm. Confirm availability with the manufacturer's instructions for use.
Is NeuWave MRI safe?
The FDA device database lists NeuWave as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is NeuWave FDA cleared?
NeuWave is covered by FDA submissions K163118, K200081, K231738.
How do I contact a NeuWave Medical, Inc. sales representative?
NeuWave Medical, Inc. has not listed representatives on LA Vascular yet. Visit the NeuWave Medical, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.