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Neuwave NWF1US1N

by NeuWave Medical, Inc.

Neuwave NWF1US1N is a microwave ablation system generator (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 00818913020196), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K163118

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818913020196 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163118 Date9 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163118 decided 9 Mar 2017 Active
  • FDA GUDID UDI-DI 00818913020196 listed 22 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163118
  2. Listed FDA GUDID 00818913020196

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neuwave
Generic name
Microwave ablation system generator
Model / Ref / Catalog
NWF1US1N
Primary DI / UDI-DI
00818913020196
510(k) Number
FDA product code
NEY
GMDN term
Microwave ablation system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Microwave ablation system generator

Cleared under the same submission (K163118)

Similar devices

Other devices filed under FDA product code NEY (SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES).

Other devices from NeuWave Medical, Inc.

See all devices from NeuWave Medical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)