510(k) K171143

Relievant Medsystems RF Generator by Relievant Medsystems — Product Code GXD

K171143 is an FDA 510(k) premarket notification submitted by Relievant Medsystems for the device "Relievant Medsystems RF Generator". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Relievant Medsystems has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2017
Date Received
April 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type