FDA 510(k)

Signia Small Diameter Reloads Including Regular (Round) Tip Version

K-Number: K222641 · 2022-11-29

Decision Date2022-11-29

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Signia Small Diameter Reloads Including Regular (Round) Tip Version is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2022-11-29 under approval number K222641. 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 Including Regular (Round) Tip Version?

Signia Small Diameter Reloads Including Regular (Round) Tip Version is a medical device that received FDA 510(k) clearance on 2022-11-29. It is manufactured by Covidien. The 510(k) number is K222641.

When was Signia Small Diameter Reloads Including Regular (Round) Tip Version approved by the FDA?

Signia Small Diameter Reloads Including Regular (Round) Tip Version received FDA 510(k) clearance on 2022-11-29, under approval number K222641.

What company makes Signia Small Diameter Reloads Including Regular (Round) Tip Version?

Signia Small Diameter Reloads Including Regular (Round) Tip Version is manufactured by Covidien.

What is the FDA product code for Signia Small Diameter Reloads Including Regular (Round) Tip Version?

The FDA product code for Signia Small Diameter Reloads Including Regular (Round) Tip Version is GDW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.