FDA 510(k)

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version

Número K: K222641 · 2022-11-29

Data da decisão2022-11-29

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-11-29 under 510(k) number K222641. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Covidien. The 510(k) number is K222641.

When did Signia™ Small Diameter Reloads Including Regular (Round) Tip Version receive FDA 510(k) clearance?

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

Who is the listed applicant for Signia™ Small Diameter Reloads Including Regular (Round) Tip Version?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

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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