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FDA 510(k)

ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm

K-Number: K160521 · 2016-03-22

ApplicantEthicon Endo-Surgery, LLC
Decision Date2016-03-22
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2016-03-22 under approval number K160521. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm?

ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K160521.

When was ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm approved by the FDA?

ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm received FDA 510(k) clearance on 2016-03-22, under approval number K160521.

What company makes ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm?

ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm?

The FDA product code for ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm is GDW.

Related Clinical Trials

NCT06691919 Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System WITHDRAWN

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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