K202864 is an FDA 510(k) clearance for the Tri-Staple 2.0 Reloads. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on October 28, 2020, 30 days after receiving the submission on September 28, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K202864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2020 |
| Decision Date | October 28, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |