The following data is part of a premarket notification filed by Relievant Medsystems, Inc. with the FDA for Intracept Intraosseous Nerve Ablation System.
| Device ID | K213836 |
| 510k Number | K213836 |
| Device Name: | Intracept Intraosseous Nerve Ablation System |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085 |
| Contact | Thomas A Slater |
| Correspondent | Thomas A Slater Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-03-11 |