510(k) K234039
K234039 is an FDA 510(k) premarket notification submitted by Lexington Medical, Inc. for the device "AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)". The FDA issued a decision of Substantially Equivalent on May 7, 2024. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Lexington Medical, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2024
- Date Received
- December 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stapler, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4740
- Review Panel
- SU
- Submission Type
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.