Medical Device Manufacturer · US , Madision , WI

Neuwave Medical, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2010

Recent clearances: ABLATE-IQ, NEUWAVE™ Microwave Ablation System and Accessories, NEUWAVE Microwave Ablation System and Accessories

15
Total
15
Cleared
0
Denied

FDA 510(k) Regulatory Record - Neuwave Medical, Inc. General & Plastic Surgery ✕

10 devices
1-10 of 10
Cleared Nov 16, 2023
NEUWAVE™ Microwave Ablation System and Accessories
K231738 · NEY
General & Plastic Surgery · 155d
Cleared Aug 11, 2022
NEUWAVE Microwave Ablation System and Accessories
K220472 · NEY
General & Plastic Surgery · 174d
Cleared Nov 13, 2020
NEUWAVE Microwave Ablation System and Accessories
K200081 · NEY
General & Plastic Surgery · 303d
Cleared Oct 24, 2018
Certus 140 2.45GHz Ablation System
K173756 · NEY
General & Plastic Surgery · 317d
Cleared Mar 09, 2017
FLEX Microwave Ablation System and Accessories
K163118 · NEY
General & Plastic Surgery · 121d
Cleared May 04, 2016
Certus 140 2.45GHz Ablation System
K160936 · NEY
General & Plastic Surgery · 30d
Cleared Jul 18, 2013
CERTUS 140 CERTUSURGGT SURGICAL TOOL
K130399 · NEY
General & Plastic Surgery · 149d
Cleared Dec 19, 2012
CERTUS 140 2.45GHZ ABLATION SYSTEM
K122217 · NEY
General & Plastic Surgery · 147d
Cleared Jan 04, 2012
CERTUS 140 2.45GHZ ABLATION SYSTEM
K113237 · NEY
General & Plastic Surgery · 63d
Cleared Oct 22, 2010
CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
K100744 · NEY
General & Plastic Surgery · 220d
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