The following data is part of a premarket notification filed by Covidien with the FDA for Tri-staple 2.0 Reloads.
| Device ID | K202864 |
| 510k Number | K202864 |
| Device Name: | Tri-Staple 2.0 Reloads |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Carolina Cabezas |
| Correspondent | Carolina Cabezas Covidien 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 | 2020-09-28 |
| Decision Date | 2020-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521808994 | K202864 | 000 |
| 20884521808987 | K202864 | 000 |
| 20884521808970 | K202864 | 000 |
| 20884521808963 | K202864 | 000 |
| 20884521808956 | K202864 | 000 |