FDA 510(k)

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload

Número K: K171561 · 2017-08-28

Data da decisão2017-08-28

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is the device name listed in this FDA 510(k) record. The listed applicant is Dextera Surgical, Inc.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K171561. 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 Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Dextera Surgical, Inc.. The 510(k) number is K171561.

When did Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload receive FDA 510(k) clearance?

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload received FDA 510(k) clearance on 2017-08-28, under 510(k) number K171561.

Who is the listed applicant for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

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

What is the FDA product code for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

The FDA product code for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is GDW.

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Dispositivos Relacionados (Código: GDW)

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