RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
FDA 510(k) clearance K992693 · decided 1999-09-10
Clearance details
- K-number
- K992693
- Device name
- RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
- Applicant
- Rita Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-08-12
- Decision date
- 1999-09-10
- 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 |
|---|---|---|
| Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877 recall (Z-1143-2015) | Angiodynamics | 2015-02-24 |
| RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: recall (Z-0752-2007) | Rita Medical Systems, Inc. | 2007-04-19 |
| RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufa recall (Z-0754-2007) | Rita Medical Systems, Inc. | 2007-04-19 |