The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament Chisels.
| Device ID | K000691 |
| 510k Number | K000691 |
| Device Name: | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-05-04 |