K112231 is an FDA 510(k) clearance for the LCCS INSULATED SPINAL NEEDLE (RF CANNULA). This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Lccs Products Limited (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on August 19, 2011, 15 days after receiving the submission on August 4, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K112231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2011 |
| Decision Date | August 19, 2011 |
| Days to Decision | 15 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 |