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FDA 510(k)

Signia Stapler (with new software)

K-Number: K201672 · 2020-07-17

ApplicantCovidien
Decision Date2020-07-17
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Signia Stapler (with new software) is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2020-07-17 under approval number K201672. 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 Signia Stapler (with new software)?

Signia Stapler (with new software) is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Covidien. The 510(k) number is K201672.

When was Signia Stapler (with new software) approved by the FDA?

Signia Stapler (with new software) received FDA 510(k) clearance on 2020-07-17, under approval number K201672.

What company makes Signia Stapler (with new software)?

Signia Stapler (with new software) is manufactured by Covidien.

What is the FDA product code for Signia Stapler (with new software)?

The FDA product code for Signia Stapler (with new software) is 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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