The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventions Model Tac-s Monopolar Cautery Probe (modify).
| Device ID | K963157 |
| 510k Number | K963157 |
| Device Name: | ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 2629 A TERMINAL BLVD. Mountain View, CA 94043 |
| Contact | Hugh Sharkey |
| Correspondent | Hugh Sharkey ORATEC INTERVENTIONS, INC. 2629 A TERMINAL BLVD. Mountain View, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-25 |
| Decision Date | 1996-09-18 |