The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Ablator-s Probes (monopolar Ablation Suction Probes).
| Device ID | K992805 |
| 510k Number | K992805 |
| Device Name: | ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Jennifer Brennan |
| Correspondent | Jennifer Brennan ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-20 |
| Decision Date | 2000-02-04 |
| Summary: | summary |