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510(k) K234039

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) by Lexington Medical, Inc. — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2024
Date Received
December 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stapler, Surgical
Device Class
Class II
Regulation Number
878.4740
Review Panel
SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Other clearances by Lexington Medical, Inc.

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  • 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)
  • K173443 — AEON Endoscopic Stapler (February 1, 2018)
  • K171589 — AEON Endoscopic Stapler (November 17, 2017)

Other clearances for product code GAG

  • K251482 — AEON™ Endoscopic Powered Stapler (July 11, 2025)
  • K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (March 10, 2025)
  • K240881 — Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapte (November 1, 2024)
  • K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
  • K231934 — GIA™ Stapler with Tri-Staple™ Technology (October 27, 2023)
  • K231491 — TA™ Stapler and Loading Unit with DST Series™ Technology (August 16, 2023)
  • K232126 — EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular S (August 16, 2023)
  • K221629 — Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (February 22, 2023)
  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)
  • K970079 — PROXIMATE DISPOSABLE SKIN STAPLER (March 11, 1997)