FDA 510(k)

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

Numéro K : K210909 · 2021-06-24

Date de décision2021-06-24

Code produitGDW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Ezisurg Medical Co., Ltd. en tant que demandeur

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges 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

Dispositifs connexes (Code : GDW)

Source officielle

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