The following data is part of a premarket notification filed by Relievant Medsystems with the FDA for Intracept Flexible Bi-polar Rf Probe And Easy Access Instrument Set.
| Device ID | K153272 |
| 510k Number | K153272 |
| Device Name: | INTRACEPT Flexible Bi-Polar RF Probe And Easy Access Instrument Set |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | RELIEVANT MEDSYSTEMS 2688 MIDDLEFIELD ROAD, SUITE A Redwood City, CA 94063 |
| Contact | Adam Savakus |
| Correspondent | Adam Savakus 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 | 2015-11-12 |
| Decision Date | 2016-07-09 |
| Summary: | summary |