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Neuwave ARM1

by NeuWave Medical, Inc.

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 FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853719006975 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

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

Similar devices

Other devices filed under FDA product code BWN (TABLE AND ATTACHMENTS, OPERATING-ROOM).

Other devices from NeuWave Medical, Inc.

  • Neuwave FLEX6

    Class II
  • Neuwave ARM2

    Class I
  • Neuwave PRS35

    Class II
  • Neuwave Rcpk

    Class II

See all devices from NeuWave Medical, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)