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FDA 510(k)

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

K-Number: K200320 · 2021-02-05

ApplicantM/s. Meril Endo Surgery Private Limited.
Decision Date2021-02-05
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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NCT05360069Linear Stapler Versus Circular Stapler in EsophagojejunostomyRECRUITING

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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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