K234039 is an FDA 510(k) clearance for the AEON Endoscopic Powered Stapler (Short/AEPH060). This device is classified as a Stapler, Surgical (Class II - Special Controls, product code GAG).
Submitted by Lexington Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on May 7, 2024, 138 days after receiving the submission on December 21, 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 | K234039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 138 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. |