Neuwave ARM1
Neuwave ARM1 is a microwave ablation system generator (FDA Class I; FDA product code BWN, Table and Attachments, Operating-Room) made by NeuWave Medical, Inc., listed in FDA GUDID since 22 Sep 2017 (UDI-DI 00853719006975), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00853719006975 | Date22 Sep 2017 | StatusListed |
Official records
- AccessGUDID record 00853719006975
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Neuwave
- Generic name
- Microwave ablation system generator
- Model / Ref / Catalog
- ARM1
- Primary DI / UDI-DI
- 00853719006975
- FDA product code
- BWN
- GMDN term
- Microwave ablation system generator
- Device class
- Class I
- Regulation number
- 878.4950
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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