K221629 is an FDA 510(k) clearance for the Tri-Staple? 2.0 Black Circular Reloads (for use with Signia? Circular Adapters), a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on February 22, 2023, 261 days after receiving the submission on June 6, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.
| 510(k) Number | K221629 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 2022 |
| Decision Date | February 22, 2023 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAG — Stapler, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4740 |
| Definition | A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses. |