Duns Number:044606982
Device Description: The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The 45 mm instruments have a staple line thatis approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portionof the shaft to facilitate lateral access of the operative site.The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from being refired.
Catalog Number
GST45T
Brand Name
ECHELON ENDOPATH
Version/Model Number
GST45T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
53bf0a73-81e8-43b6-9267-376b405e0ba1
Public Version Date
December 07, 2021
Public Version Number
6
DI Record Publish Date
February 22, 2017
Package DI Number
30705036014915
Quantity per Package
420
Contains DI Package
10705036014911
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |