FDA.reportPublic FDA data

Echelon Linear Cutter

Primary DI
30705036030892
Brand
Echelon Linear Cutter
Company
ETHICON ENDO-SURGERY, LLC
Model
GLC100
Catalog number
GLC100
Device description
Echelon Linear Cutter 100mm
Published
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAGStapler, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

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
20705036030895PackageGS13In Commercial Distribution
30705036030892PackageGS112In Commercial Distribution
40705036030899PackageGS13In Commercial Distribution
10705036030898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503603089520705036030895
3070503603089230705036030892
4070503603089940705036030899
1070503603089810705036030898

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
044606982
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
20612479282852McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282883McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282890McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282906McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282913McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282920McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282937McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282944McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283019McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283194McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283200McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283217McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283224McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283231McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283248McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283255McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284597McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284641McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284986McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285006McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285020McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285105McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
00190776409500MillenniumAvalign Technologies, Inc.GAG2025-09-02
10705036043522ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043539ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043546ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043529ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043536ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043543ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10888277368293MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14