RITA MODEL 70 ELECTROSURGICAL PROBE
FDA 510(k) clearance K983871 · decided 1998-12-01
Clearance details
- K-number
- K983871
- Device name
- RITA MODEL 70 ELECTROSURGICAL PROBE
- Applicant
- Rita Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1998-11-02
- Decision date
- 1998-12-01
- Days to decision
- 29 days
- Clearance type
- Special
- 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
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RIT recall (Z-0753-2007) | Rita Medical Systems, Inc. | 2007-04-19 |