510(k) K191293

LCCS VC-S RF Cannula by Lccs Products Limited — Product Code GXI

K191293 is an FDA 510(k) premarket notification submitted by Lccs Products Limited for the device "LCCS VC-S RF Cannula". The FDA issued a decision of Substantially Equivalent on January 24, 2020. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Lccs Products Limited has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2020
Date Received
May 14, 2019
Clearance Type
Traditional
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