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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010601421 | K003893 | 000 |
| 03596010470447 | K003893 | 000 |
| 03596010470430 | K003893 | 000 |
| 03596010470423 | K003893 | 000 |
| 03596010470416 | K003893 | 000 |
| 03596010470409 | K003893 | 000 |
| 03596010470393 | K003893 | 000 |
| 03596010470386 | K003893 | 000 |
| 03596010470379 | K003893 | 000 |
| 03596010470362 | K003893 | 000 |
| 03596010470355 | K003893 | 000 |
| 03596010470348 | K003893 | 000 |
| 03596010470454 | K003893 | 000 |
| 03596010470461 | K003893 | 000 |
| 03596010470478 | K003893 | 000 |
| 03596010601414 | K003893 | 000 |
| 03596010505354 | K003893 | 000 |
| 03596010505194 | K003893 | 000 |
| 03596010505170 | K003893 | 000 |
| 03596010505149 | K003893 | 000 |
| 03596010505132 | K003893 | 000 |
| 03596010470676 | K003893 | 000 |
| 03596010470669 | K003893 | 000 |
| 03596010470584 | K003893 | 000 |
| 03596010470577 | K003893 | 000 |
| 03596010470485 | K003893 | 000 |
| 03596010470331 | K003893 | 000 |