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FDA 510(k)

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black

K-Number: K183435 · 2019-02-06

ApplicantEthicon Endo-Surgery, LLC
Decision Date2019-02-06
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2019-02-06 under approval number K183435. 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 Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black?

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black is a medical device that received FDA 510(k) clearance on 2019-02-06. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K183435.

When was Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black approved by the FDA?

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black received FDA 510(k) clearance on 2019-02-06, under approval number K183435.

What company makes Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black?

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black?

The FDA product code for Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black is GDW.

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Related Devices (Code: GDW)

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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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