510(k) K190259

Vesta RF Cannula by Biomerics — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2020
Date Received
February 7, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type