The following data is part of a premarket notification filed by Relievant Medsystems with the FDA for Intracept Intraosseous Nerve Ablation System.
| Device ID | K170827 |
| 510k Number | K170827 |
| Device Name: | INTRACEPT Intraosseous Nerve Ablation System |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Relievant Medsystems 2688 Middlefield Road, Suite A Redwood City, CA 94063 |
| Contact | Alex Dinello |
| Correspondent | Laurie Hook Relievant Medsystems 2688 Middlefield Road, Suite A Redwood City, CA 94063 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2017-08-09 |
| Summary: | summary |