FDA 510(k)

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

Numéro K : K200320 · 2021-02-05

DemandeurM/s. Meril Endo Surgery Private Limited.

Date de décision2021-02-05

Code produitGDW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K200320. 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 Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload?

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K200320.

When did Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload receive FDA 510(k) clearance?

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload received FDA 510(k) clearance on 2021-02-05, under 510(k) number K200320.

Who is the listed applicant for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload?

The FDA product code for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload is GDW.

Essais cliniques associés

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Dispositifs connexes (Code : GDW)

Source officielle

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