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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
Endoscopic Linear Cutter Reloads Gray 2.0mm, 6 rows FDA UDI
Model / Reference
ECR60M FDA UDI
Description
Endoscopic Linear Cutter Reloads Gray 2.0mm, 6 rows FDA UDI

Identifiers

Catalog Number
ECR60M FDA UDI
Primary DI / UDI-DI
10705036013792 FDA UDI
510(k) Number
K080839 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.

Cleared under the same submission

K080839 also covers:

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 5cac8c3d-bb6a-4013-8705-506a92b968ad 36 fields · synced May 31, 2026