K231934 is an FDA 510(k) clearance for the GIA? Stapler with Tri-Staple? Technology, a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Covidien (Min Hang District, Shanghai, CN). The FDA issued a Cleared decision on October 27, 2023, 119 days after receiving the submission on June 30, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.
| 510(k) Number | K231934 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 30, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 119 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. |