The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Vulcan Ablator Electrosurgical Probes, Vulcan Ligament Chisel Electrosurgical Probes, Model 91000x,91002x,91300x.
| Device ID | K003893 |
| 510k Number | K003893 |
| Device Name: | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X |
| Classification | Arthroscope |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie 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 | 2000-12-18 |
| Decision Date | 2001-03-01 |