K251482
- 510(k) number
- K251482
- Device name
- AEON Endoscopic Powered Stapler
- Applicant
- Lexington Medical, Inc. MA · US
- Product code
- GAG — Stapler, Surgical
- Decision date
- 2025-07-11
- Date received
- 2025-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251482.pdf
Official FDA record: K251482
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.