510(k) K152642

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode by Lccs Products Limited — Product Code GXI

K152642 is an FDA 510(k) premarket notification submitted by Lccs Products Limited for the device "LCCS Disposable RF Electrode, LCCS Reusable RF Electrode". The FDA issued a decision of Substantially Equivalent on August 26, 2016. 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
August 26, 2016
Date Received
September 15, 2015
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