The following data is part of a premarket notification filed by Covidien with the FDA for Tri-staple 2.0 Reinforced Reload.
| Device ID | K173270 |
| 510k Number | K173270 |
| Device Name: | Tri-Staple 2.0 Reinforced Reload |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Ave. North Haven, CT 06473 |
| Contact | Rebecca Magnanimo |
| Correspondent | Rebecca Magnanimo Covidien 60 Middletown Ave. North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-12 |
| Decision Date | 2018-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521717630 | K173270 | 000 |
| 20884521717623 | K173270 | 000 |
| 20884521717616 | K173270 | 000 |
| 20884521717609 | K173270 | 000 |