K213836 is an FDA 510(k) clearance for the Intracept Intraosseous Nerve Ablation System. This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Relievant Medsystems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 11, 2022, 92 days after receiving the submission on December 9, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K213836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2021 |
| Decision Date | March 11, 2022 |
| Days to Decision | 92 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 |