K234039
- 510(k) number
- K234039
- Device name
- AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
- Applicant
- Lexington Medical, Inc. MA · US
- Product code
- GAG — Stapler, Surgical
- Decision date
- 2024-05-07
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K234039.pdf
Official FDA record: K234039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.