510(k) K152642
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