RITA STARBURST XLI ELECTROSURGICAL DEVICE
FDA 510(k) clearance K010060 · decided 2001-01-23
Clearance details
- K-number
- K010060
- Device name
- RITA STARBURST XLI ELECTROSURGICAL DEVICE
- Applicant
- Rita Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-01-08
- Decision date
- 2001-01-23
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mountain View, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Ta recall (Z-0887-06) | Rita Medical Systems, Inc. | 2006-05-31 |
| XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst X recall (Z-0888-06) | Rita Medical Systems, Inc. | 2006-05-31 |