FDA.reportPublic FDA data

Echelon Linear Cutter

Primary DI
10705036027898
Brand
Echelon Linear Cutter
Company
ETHICON ENDO-SURGERY, LLC
Model
GLCR80B
Catalog number
GLCR80B
Device description
Echelon Linear Cutter Reload 80mm BLUE
Published
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K223760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223760000ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)Ethicon Endo-Surgery2023-03-15GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705036027895PackageGS112In Commercial Distribution
30705036027892PackageGS196In Commercial Distribution
10705036027898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503602789520705036027895
3070503602789230705036027892
1070503602789810705036027898

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
044606982
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705036046523Megadyne2255JTES2255JTES2026-05-27
10705036003113HARMONICTLB01TLB012016-07-15
20705036003271HARMONICTTBLUETTBLUE2016-07-15
20705036013904N/ACRT11CRT112016-07-15
20705036038396DUALTO Energy SystemETHEF2ETHEF22025-06-18
20705036038402DUALTO Energy SystemETHEF1ETHEF12025-06-18
20705036038419DUALTO Energy SystemETHERFETHERF2025-06-18
20705036038426DUALTO Energy SystemETHCRTETHCRT2025-06-18
20705036039287DUALTO Energy SystemETHOVKETHOVK2025-06-20
20705036038365DUALTO Energy SystemETHCMETHCM2025-06-18
20705036038372DUALTO Energy SystemETHUSCETHUSC2025-06-18
20705036038389DUALTO Energy SystemETHEMETHEM2025-06-18
10705036013143ProximateTCT55TCT552015-08-24
10705036013204PROXIMATETLC55TLC552015-08-24
10705036013006ProximatePPH03PPH032015-08-24
10705036013112ProximateTCD75TCD752015-08-24
10705036013150PROXIMATETCT75TCT752015-08-24
10705036013211PROXIMATETLC75TLC752015-08-24
10705036013389PROXIMATETVC55TVC552015-08-24
10705036002895ETHIBOND; DURAKNOTSW110SW1102016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06925776121404easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-26
06925776121428easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-26
06925776106050easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106067easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106074easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106081easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106098easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106104easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106111easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106128easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106135easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106142easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776121923easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121930easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121947easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121954easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121961easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121978easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121985easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121992easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122005easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122012easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122029easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122036easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
00190776431129MillenniumAvalign Technologies, Inc.GAG2026-09-21
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703827Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGAG2026-08-09