FDA 510(k)

ConvertX Nephroureteral Stent System

Número K: K161277 · 2016-11-22

Data da decisão2016-11-22

Código do produtoFAD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ConvertX Nephroureteral Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Brightwater Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161277. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ConvertX Nephroureteral Stent System?

ConvertX Nephroureteral Stent System is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Brightwater Medical. The 510(k) number is K161277.

When did ConvertX Nephroureteral Stent System receive FDA 510(k) clearance?

ConvertX Nephroureteral Stent System received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161277.

Who is the listed applicant for ConvertX Nephroureteral Stent System?

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

What is the FDA product code for ConvertX Nephroureteral Stent System?

The FDA product code for ConvertX Nephroureteral Stent System is FAD.

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Outros registros que listam Brightwater Medical como candidato(a)

K181669ConvertX Biliary Stent System

Dispositivos Relacionados (Código: FAD)

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Fonte oficial

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