AEON Endoscopic Stapler— 510(k) K201882

Name: FDA 510(k) clearance K201882
Creator: U.S. Food and Drug Administration
Published: 2020-10-09

Substantially Equivalent

Lexington Medical, Inc.

FDA 510(k) clearance K201882 for AEON Endoscopic Stapler, Substantially Equivalent on 2020-10-09. Applicant: Lexington Medical, Inc.. Device class: 2.

Clearance details

Applicant: Lexington Medical, Inc.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2020-07-08
Decision date: 2020-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDW

view all

K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

More clearances from Lexington Medical, Inc.

view all

K251482 — AEON Endoscopic Powered Stapler2025-07-11
K234039 — AEON Endoscopic Powered Stapler (3 models)2024-05-07
K222210 — AEON Endoscopic Stapler2023-04-21
K192235 — AEON Laparoscopic Instruments2019-10-11
K182380 — AEON Endoscopic Stapler2018-11-28

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.