The following data is part of a premarket notification filed by Relievant Medsystems with the FDA for Intracept Intraosseous Nerve Ablation System (component Intracept Rf Probe).
| Device ID | K180369 |
| 510k Number | K180369 |
| Device Name: | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Relievant Medsystems 385 Moffett Park Drive, Suite 105 Sunnyvale, CA 94089 |
| Contact | Alex Dinello |
| Correspondent | Alex Dinello Relievant Medsystems 385 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 | 2018-02-12 |
| Decision Date | 2018-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852454006219 | K180369 | 000 |