MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
FDA 510(k) clearance K140170 · decided 2014-02-19
Clearance details
- K-number
- K140170
- Device name
- MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
- Applicant
- Cardica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-23
- Decision date
- 2014-02-19
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridg recall (Z-0482-2016) | Cardica, Inc. | 2015-12-24 |
| MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter recall (Z-0483-2016) | Cardica, Inc. | 2015-12-24 |