K232126 is an FDA 510(k) clearance for the EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil. This device is classified as 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 August 16, 2023, 30 days after receiving the submission on July 17, 2023.
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 | K232126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2023 |
| Decision Date | August 16, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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. |