The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Starburst Xli Electrosurgical Device.
| Device ID | K010060 |
| 510k Number | K010060 |
| Device Name: | RITA STARBURST XLI ELECTROSURGICAL DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Erin Mazzone |
| Correspondent | Michael Kwan UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7877001040771 | K010060 | 000 |
| H7877001030271 | K010060 | 000 |
| H7877001030241 | K010060 | 000 |
| H7877001028471 | K010060 | 000 |
| H7877001028461 | K010060 | 000 |
| H7877001028451 | K010060 | 000 |