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FDA 510(k)

Signia Small Diameter Reloads

K-Number: K191070 · 2019-09-04

ApplicantCovidien
Decision Date2019-09-04
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Signia Small Diameter Reloads is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2019-09-04 under approval number K191070. 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 Small Diameter Reloads?

Signia Small Diameter Reloads is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Covidien. The 510(k) number is K191070.

When was Signia Small Diameter Reloads approved by the FDA?

Signia Small Diameter Reloads received FDA 510(k) clearance on 2019-09-04, under approval number K191070.

What company makes Signia Small Diameter Reloads?

Signia Small Diameter Reloads is manufactured by Covidien.

What is the FDA product code for Signia Small Diameter Reloads?

The FDA product code for Signia Small Diameter Reloads 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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