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Neuwave FLEX6

by NeuWave Medical, Inc.

Neuwave FLEX6 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 00853719006326), active as of 22 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 22 Oct 2026

Documents

510(k) K163118

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853719006326 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 00853719006326 listed 22 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163118
  2. Listed FDA GUDID 00853719006326

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  • Withdrawn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 probe, non-powered
Model / Ref / Catalog
FLEX6
Primary DI / UDI-DI
00853719006326
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
Length — 150 Centimeter
Outer Diameter — 2 Millimeter

Related devices

Category: Microwave ablation system probe, non-powered

Cleared under the same submission (K163118)

Similar devices in this category

Other devices filed under Microwave ablation system probe, non-powered.

Other devices from NeuWave Medical, Inc.

See all devices from NeuWave Medical, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)