AEON Endoscopic Powered Stapler— 510(k) K251482
Substantially EquivalentLexington Medical, Inc.
FDA 510(k) clearance K251482 for AEON Endoscopic Powered Stapler, Substantially Equivalent on 2025-07-11. Applicant: Lexington Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Lexington Medical, Inc.
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code GAG
view all- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) +1 more
- K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more
- K234039 — AEON Endoscopic Powered Stapler (3 models)
More clearances from Lexington Medical, Inc.
view allAdverse events under product code GAG
product code GAG- Death
- 23
- Injury
- 394
- Malfunction
- 2,304
- Other
- 6
- Total
- 2,727
Source: openFDA MAUDE database, through . 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.