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 | K222281 |
| 510k Number | K222281 |
| 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 | 2022-07-29 |
| Decision Date | 2022-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852454006257 | K222281 | 000 |
| 00852454006240 | K222281 | 000 |
| 00852454006233 | K222281 | 000 |
| 00852454006226 | K222281 | 000 |
| 00852454006301 | K222281 | 000 |