The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System And Accessories.
| Device ID | K991140 |
| 510k Number | K991140 |
| Device Name: | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Sheila Ramerman |
| Correspondent | Sheila Ramerman 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 | 1999-04-05 |
| Decision Date | 1999-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010613561 | K991140 | 000 |
| 00885554013160 | K991140 | 000 |
| 00885554012996 | K991140 | 000 |
| 00885554012378 | K991140 | 000 |
| 00885554011951 | K991140 | 000 |
| 00885554011890 | K991140 | 000 |
| 00885554011715 | K991140 | 000 |
| 00885554011142 | K991140 | 000 |
| 00885554010770 | K991140 | 000 |
| 00885554008609 | K991140 | 000 |
| 00885554007930 | K991140 | 000 |
| 00885554007602 | K991140 | 000 |
| 00885554007404 | K991140 | 000 |
| 00885554006834 | K991140 | 000 |
| 00885554015829 | K991140 | 000 |
| 00885554031232 | K991140 | 000 |
| 00885556539651 | K991140 | 000 |
| 03596010612793 | K991140 | 000 |
| 03596010554024 | K991140 | 000 |
| 03596010542182 | K991140 | 000 |
| 03596010534408 | K991140 | 000 |
| 03596010519405 | K991140 | 000 |
| 03596010519399 | K991140 | 000 |
| 03596010492326 | K991140 | 000 |
| 03596010480521 | K991140 | 000 |
| 03596010470591 | K991140 | 000 |
| 03596010470546 | K991140 | 000 |
| 00885556603321 | K991140 | 000 |
| 00885556586358 | K991140 | 000 |
| 00885556586341 | K991140 | 000 |
| 00885554006353 | K991140 | 000 |