FDA.reportPublic FDA data

Echelon Linear Cutter

Primary DI
10705036030874
Brand
Echelon Linear Cutter
Company
ETHICON ENDO-SURGERY, LLC
Model
GLC60
Catalog number
GLC60
Device description
Echelon Linear Cutter 60mm
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
20705036030871PackageGS13In Commercial Distribution
30705036030878PackageGS112In Commercial Distribution
10705036030874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503603087120705036030871
3070503603087830705036030878
1070503603087410705036030874

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery manual linear cutting stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

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