AEON Endoscopic Powered Stapler— 510(k) K251482

Substantially Equivalent

Lexington Medical, Inc.

FDA 510(k) clearance K251482 for AEON Endoscopic Powered Stapler, Substantially Equivalent on 2025-07-11. Applicant: Lexington Medical, Inc..

Clearance details

Applicant: Lexington Medical, Inc.
Product code: Code GAG
Advisory panel: General Hospital
Date received: 2025-05-14
Decision date: 2025-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAG

product code GAG

Death: 23
Injury: 394
Malfunction: 2,304
Other: 6
Total: 2,727

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.