The following data is part of a premarket notification filed by Covidien with the FDA for Signia Stapler.
| Device ID | K160176 |
| 510k Number | K160176 |
| Device Name: | Signia Stapler |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06471 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli Covidien 60 Middletown Avenue North Haven, CT 06471 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521543829 | K160176 | 000 |
| 20884521543659 | K160176 | 000 |
| 20884521543604 | K160176 | 000 |
| 20884521543598 | K160176 | 000 |
| 20884521543581 | K160176 | 000 |
| 20884521543574 | K160176 | 000 |
| 20884521543567 | K160176 | 000 |
| 20884521543550 | K160176 | 000 |
| 20884521543796 | K160176 | 000 |
| 10884521543867 | K160176 | 000 |
| 10884521543782 | K160176 | 000 |
| 10884521543812 | K160176 | 000 |
| 20884521543505 | K160176 | 000 |
| 20884521543499 | K160176 | 000 |
| 10884521543874 | K160176 | 000 |
| 20884521543673 | K160176 | 000 |
| 20884521543680 | K160176 | 000 |
| 20884521543697 | K160176 | 000 |
| 10884521543805 | K160176 | 000 |
| 20884521543765 | K160176 | 000 |
| 20884521543758 | K160176 | 000 |
| 20884521543741 | K160176 | 000 |
| 20884521543727 | K160176 | 000 |
| 20884521543710 | K160176 | 000 |
| 20884521543666 | K160176 | 000 |
| 20884521543642 | K160176 | 000 |
| 20884521543635 | K160176 | 000 |
| 20884521543628 | K160176 | 000 |
| 20884521543611 | K160176 | 000 |
| 20884521543772 | K160176 | 000 |
| 20884521543734 | K160176 | 000 |
| 20884521543703 | K160176 | 000 |
| 10884521543881 | K160176 | 000 |