FDA.reportPublic FDA data

510(k) K251482

Device
AEON™ Endoscopic Powered Stapler
Applicant
Lexington Medical, Inc.
510(k) number
K251482
Product code
GAG
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-11
Date received
2025-05-14
Regulation
878.4740
Classification name
Stapler, Surgical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Sharon Timberlake
Address
23 Crosby Dr. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.2025-03-10
K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)2024-11-01
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K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.2024-05-07
K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien2023-10-27
K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien2023-08-16
K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilCovidien2023-08-16
K221629Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Covidien2023-02-22
K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC2022-04-08
K970079PROXIMATE DISPOSABLE SKIN STAPLEREthicon Endo-Surgery, Inc.1997-03-11
K962258ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIPEthicon Endo-Surgery, Inc.1996-09-11
K934188DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CARTDeroyal Industries, Inc.1994-03-28
K934105DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLESSurgical Innovations Corp.1994-03-28
K932476PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLEREthicon Endo-Surgery, Inc.1993-12-01
K933901REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)Richard-Allan Medical1993-11-19