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Echelon Endopath

FDA UDI

Class II (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

Identity

Trade Name
ECHELON ENDOPATH FDA UDI
Generic Name
Surgical staple loading unit, non-cutting FDA UDI
Device Name
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. FDA UDI
Model / Reference
GST45B FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
GST45B FDA UDI
Primary DI / UDI-DI
10705036014881 FDA UDI
FDA Product Code
GDW FDA UDI
GMDN Term
Surgical staple loading unit, non-cutting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Surgical staple loading unit, non-cutting

Echelon Endopath by Ethicon Endo-Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical staple loading unit, non-cutting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA UDI 34f31c66-0f8a-4263-82d7-e02ba33315b3 35 fields · synced May 30, 2026