K221003 is an FDA 510(k) clearance for the Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA. 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 September 30, 2022, 178 days after receiving the submission on April 5, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K221003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2022 |
| Decision Date | September 30, 2022 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| 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 |