Neuwave PRS35
Neuwave PRS35 is a microwave ablation system probe (FDA Class II; FDA product code NEY, System, Ablation, Microwave and Accessories) made by NeuWave Medical, Inc., cleared under FDA 510(k) K231738 on 16 Nov 2023 and listed in FDA GUDID since 14 Jun 2024 (UDI-DI 10818913020698), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10818913020698 | Date14 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231738 | Date16 Nov 2023 | StatusActive |
Official records
- AccessGUDID record 10818913020698
- FDA 510(k) database K231738
Across registries
- FDA 510(k) K231738 decided 16 Nov 2023 Active
- FDA GUDID UDI-DI 10818913020698 listed 14 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K231738
- Listed FDA GUDID 10818913020698
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neuwave
- Generic name
- Microwave ablation system probe, non-powered
- Model / Ref / Catalog
- PRS35
- Primary DI / UDI-DI
- 10818913020698
- 510(k) Number
- FDA product code
- NEY
- GMDN term
- Microwave ablation system probe, non-powered
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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