The following data is part of a premarket notification filed by Relievant Medsystems with the FDA for Intracept Intraosseous Nerve Ablation System (rf Probe), Intracept Intraosseous Nerve Ablation System (access Instruments), Relievant Rf Generator.
| Device ID | K190504 |
| 510k Number | K190504 |
| Device Name: | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Relievant Medsystems 358 Moffett Park Drive, Suite 105 Sunnyvale, CA 94089 |
| Contact | Alex Dinello |
| Correspondent | Laurie Hook Relievant Medsystems 358 Moffett Park Drive, Suite 105 Sunnyvale, CA 94089 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-05-03 |