STARION INSTRUMENTS THERMAL LITIGATING SHEARS
FDA 510(k) clearance K062257 · decided 2006-10-10
Clearance details
- K-number
- K062257
- Device name
- STARION INSTRUMENTS THERMAL LITIGATING SHEARS
- Applicant
- Starion Instruments
- Decision
- Substantially Equivalent
- Date received
- 2006-08-04
- Decision date
- 2006-10-10
- Days to decision
- 67 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
- Saratoga, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 1 recall (Z-2239-2010) | Starion Instruments | 2010-08-19 |
| Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting recall (Z-1972-2010) | Starion Instruments | 2010-07-09 |