FDA.reportPublic FDA data

AEON

Primary DI
00850060791048
Brand
AEON
Company
LEXINGTON MEDICAL, INC.
Model
AEPH060
Device description
Endoscopic Powered Stapler - Short
Published
2024-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAGStapler, Surgical
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234039000AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.2024-05-07GAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850060791048PrimaryGS10
00851574008356Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850060791048008500607910488500607910480850060791048
00851574008356008515740083568515740083560851574008356

GMDN Terms#

Term, Definition table
TermDefinition
Motorized cutting stapler handpieceA hand-held, electrically-powered proximal component of a motorized cutting stapler designed to be used during endoscopic transection and resection of tissues and the creation of anastomoses, and/or during open surgery. It is typically a pistol-like device with battery pack, motor, and controls, and is intended to accept a separate connector endpiece/loading unit (neither are included) to cut the tissue and simultaneously apply surgical staples along the cut line. This is a reusable device.

Regulatory Flags#

DUNS number
079881514
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060791147AEONASR45PS2025-05-01
00850060791154AEONASR45PS2025-05-01
00850060791130AEONASR45WS2025-02-18
00850060791116AEONASR45RS2025-01-09
00850060791109AEONASR45RS2025-01-09
00850060791062AEONAEPH0602024-06-05
00850060791079AEONAEPH1602024-06-05
00850060791086AEONAEPH2602024-06-05
00850060791031AEONAEPH2602024-05-24
00850060791055AEONAEPH1602024-05-24
00851574008639AEONAEPH2602024-05-24
00851574008356AEONAEPH0602024-05-24
00851574008479AEONAEPH1602024-05-24
00851574008745AEONARBS3002018-06-01
00851574008783AEONARBL9992018-06-01
00851574008042AEONAESC60G2024-01-01
00851574008097AEONAESR60G2024-01-01
00851574008790AEONASR60GC2024-01-01
00851574008059AEONAESR60G2024-01-01
00851574008363AEONAETH1602023-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255200005MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200012MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200029MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909590MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909606MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909613MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909620MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909637MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909644MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909941MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909958MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909965MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909972MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909989MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
10705036040798ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040811ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040828ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040859ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036043522ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043539ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043546ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15