FDA 510(k)

ProteXsure Safety Capsule System

Número K: K152597 · 2016-06-08

RequerenteStarcap Medical, LLC ( Dba Prism Medical & Design)

Data da decisão2016-06-08

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProteXsure Safety Capsule System is the device name listed in this FDA 510(k) record. The listed applicant is Starcap Medical, LLC ( Dba Prism Medical & Design). It received FDA 510(k) clearance on 2016-06-08 under 510(k) number K152597. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ProteXsure Safety Capsule System?

ProteXsure Safety Capsule System is a medical device that received FDA 510(k) clearance on 2016-06-08. The listed applicant is Starcap Medical, LLC ( Dba Prism Medical & Design). The 510(k) number is K152597.

When did ProteXsure Safety Capsule System receive FDA 510(k) clearance?

ProteXsure Safety Capsule System received FDA 510(k) clearance on 2016-06-08, under 510(k) number K152597.

Who is the listed applicant for ProteXsure Safety Capsule System?

The FDA 510(k) record lists Starcap Medical, LLC ( Dba Prism Medical & Design) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProteXsure Safety Capsule System?

The FDA product code for ProteXsure Safety Capsule System is FMI.

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