The following data is part of a premarket notification filed by Covidien Llc with the FDA for Signia Loading Unit, Tri-staple 2.0 Cartridge.
| Device ID | K151163 |
| 510k Number | K151163 |
| Device Name: | Signia Loading Unit, Tri-Staple 2.0 Cartridge |
| Classification | Staple, Implantable |
| Applicant | Covidien LLC 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli Covidien LLC 60 Middletown Avenue North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-05-29 |
| Summary: | summary |