Neuwave FLEX4
Neuwave FLEX4 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) K163118 on 9 Mar 2017 and listed in FDA GUDID since 22 Sep 2017 (UDI-DI 00853719006319), active as of 22 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 | Number00853719006319 | Date22 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163118 | Date9 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 00853719006319
- FDA 510(k) database K163118
Across registries
- FDA 510(k) K163118 decided 9 Mar 2017 Active
- FDA GUDID UDI-DI 00853719006319 listed 22 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K163118
- Listed FDA GUDID 00853719006319
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- Withdrawn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
- FLEX4
- Primary DI / UDI-DI
- 00853719006319
- 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
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Unsafe
- Size
- Outer Diameter — 2 MillimeterLength — 150 Centimeter
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