K163098 is an FDA 510(k) clearance for the Tri-Staple 2.0 Intelligent Cartridge. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on December 5, 2016, 28 days after receiving the submission on November 7, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K163098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2016 |
| Decision Date | December 05, 2016 |
| Days to Decision | 28 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 |