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Neuwave Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232227ABLATE-IQApril 4, 2024
K231738NEUWAVE™ Microwave Ablation System and AccessoriesNovember 16, 2023
K220472NEUWAVE Microwave Ablation System and AccessoriesAugust 11, 2022
K200081NEUWAVE Microwave Ablation System and AccessoriesNovember 13, 2020
K192427Ablation ConfirmationOctober 3, 2019
K173756Certus 140 2.45GHz Ablation SystemOctober 24, 2018
K171022Ablation ConfirmationMay 9, 2017
K163118FLEX Microwave Ablation System and AccessoriesMarch 9, 2017
K161285Ablation ConfirmationJune 29, 2016
K160936Certus 140 2.45GHz Ablation SystemMay 4, 2016
K150313Ablation ConfirmationJuly 9, 2015
K130399CERTUS 140 CERTUSURGGT SURGICAL TOOLJuly 18, 2013
K122217CERTUS 140 2.45GHZ ABLATION SYSTEMDecember 19, 2012
K113237CERTUS 140 2.45GHZ ABLATION SYSTEMJanuary 4, 2012
K100744CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140October 22, 2010