FDA 510(k)

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

K-Number: K210909 · 2021-06-24

Decision Date2021-06-24

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K210909. 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 easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use?

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K210909.

When did easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use receive FDA 510(k) clearance?

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use received FDA 510(k) clearance on 2021-06-24, under 510(k) number K210909.

Who is the listed applicant for easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use?

The FDA 510(k) record lists Ezisurg Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use?

The FDA product code for easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use is GDW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07385508Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined ApproachesRECRUITING

Other records listing Ezisurg Medical Co., Ltd. as applicant

K183477easyPPHTM Hemorrhoidal Stapler for Single Use K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Related Devices (Code: GDW)

Official Source

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