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, Model Fg0018 (probe), Fg0036 (instrument Set).
| Device ID | K100641 |
| 510k Number | K100641 |
| Device Name: | INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2010-03-30 |
| Summary: | summary |