K221629 is an FDA 510(k) clearance for the Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters). This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4740. 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..
| 510(k) Number | K221629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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. |