Home / 510(k) Clearances / K173443

510(k) K173443

AEON Endoscopic Stapler by Lexington Medical, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2018
Date Received
November 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Lexington Medical, Inc.

  • K251482 — AEON™ Endoscopic Powered Stapler (July 11, 2025)
  • K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (May 7, 2024)
  • K222210 — AEON Endoscopic Stapler (April 21, 2023)
  • K201882 — AEON Endoscopic Stapler (October 9, 2020)
  • K192235 — AEON Laparoscopic Instruments (October 11, 2019)
  • K182380 — AEON Endoscopic Stapler (November 28, 2018)
  • K180114 — AEON Retrieval Bag (March 27, 2018)
  • K171589 — AEON Endoscopic Stapler (November 17, 2017)

Other clearances for product code GDW

  • K252739 — ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapl (December 17, 2025)
  • K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (May 14, 2025)
  • K243276 — ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapl (February 25, 2025)
  • K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (October 28, 2024)
  • K242679 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm (October 4, 2024)
  • K222487 — Anika Tissue Tack Fixation System (May 8, 2023)
  • K222210 — AEON Endoscopic Stapler (April 21, 2023)
  • K223760 — ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELO (March 15, 2023)
  • K211197 — Disposable Endoscopic Cutter Stapler and Cartridge (January 19, 2023)
  • K221771 — EEA Circular Stapler with Tri-Staple Technology (November 30, 2022)