← Back to catalogue

Echelon Flex

FDA UDI

Class II (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

Identity

Trade Name
ECHELON FLEX FDA UDI
Generic Name
Endoscopic motorized cutting stapler, single-use FDA UDI
Device Name
The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload. FDA UDI
Model / Reference
PSEE45A FDA UDI
Description
The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload. FDA UDI

Identifiers

Catalog Number
PSEE45A FDA UDI
Primary DI / UDI-DI
10705036015352 FDA UDI
FDA Product Code
GDW FDA UDI
GMDN Term
Endoscopic motorized cutting stapler, single-use 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

No

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

Category: Endoscopic motorized cutting stapler, single-use

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

Similar devices

Also classified as Endoscopic motorized cutting stapler, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA UDI da74327e-f994-4b3d-be9e-d46459cc7bcb 36 fields · synced May 29, 2026