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FDA 510(k)

AEON™ Endoscopic Powered Stapler

K-Number: K251482 · 2025-07-11

ApplicantLexington Medical, Inc.
Decision Date2025-07-11
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AEON™ Endoscopic Powered Stapler is a medical device manufactured by Lexington Medical, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K251482. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEON™ Endoscopic Powered Stapler?

AEON™ Endoscopic Powered Stapler is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Lexington Medical, Inc.. The 510(k) number is K251482.

When was AEON™ Endoscopic Powered Stapler approved by the FDA?

AEON™ Endoscopic Powered Stapler received FDA 510(k) clearance on 2025-07-11, under approval number K251482.

What company makes AEON™ Endoscopic Powered Stapler?

AEON™ Endoscopic Powered Stapler is manufactured by Lexington Medical, Inc..

What is the FDA product code for AEON™ Endoscopic Powered Stapler?

The FDA product code for AEON™ Endoscopic Powered Stapler is GAG.

Related Clinical Trials

NCT06691919 Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System WITHDRAWN

Other Devices by Lexington Medical, Inc.

K171589AEON Endoscopic Stapler K182380AEON Endoscopic Stapler K180114AEON Retrieval Bag K173443AEON Endoscopic Stapler K192235AEON Laparoscopic Instruments K201882AEON Endoscopic Stapler

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Related Devices (Code: GAG)

K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilCovidien K221629Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Covidien K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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