K152642 is an FDA 510(k) clearance for the LCCS Disposable RF Electrode, LCCS Reusable RF Electrode. This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Lccs Products Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 26, 2016, 346 days after receiving the submission on September 15, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K152642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2015 |
| Decision Date | August 26, 2016 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXI - Probe, Radiofrequency Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4725 |