510(k) K220472

NEUWAVE Microwave Ablation System and Accessories by Neuwave Medical, Inc. — Product Code NEY

K220472 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "NEUWAVE Microwave Ablation System and Accessories". The FDA issued a decision of Substantially Equivalent on August 11, 2022. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Neuwave Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2022
Date Received
February 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type