510(k) K132581 ยท GDW Staple, Implantable
MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
| Applicant | Cardica, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 7, 2014 |
| Received | Aug 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2015 | Cardica, Inc. MicroCutter Xchange 30 Blue Cartridge, FG-025320;
The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges ar Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.