FDA 510(k)

easyPPHTM Hemorrhoidal Stapler for Single Use

Numéro K : K183477 · 2019-02-11

Date de décision2019-02-11

Code produitGDW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

easyPPHTM Hemorrhoidal Stapler 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 2019-02-11 under 510(k) number K183477. 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 easyPPHTM Hemorrhoidal Stapler for Single Use?

easyPPHTM Hemorrhoidal Stapler for Single Use is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K183477.

When did easyPPHTM Hemorrhoidal Stapler for Single Use receive FDA 510(k) clearance?

easyPPHTM Hemorrhoidal Stapler for Single Use received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183477.

Who is the listed applicant for easyPPHTM Hemorrhoidal Stapler 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 easyPPHTM Hemorrhoidal Stapler for Single Use?

The FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use is GDW.

Essais cliniques associés

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

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Dispositifs connexes (Code : GDW)

Source officielle

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