FDA 510(k)

PathKeeper System

Número K: K222355 · 2023-03-08

Data da decisão2023-03-08

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PathKeeper System is the device name listed in this FDA 510(k) record. The listed applicant is Pathkeeper Surgical , Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K222355. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PathKeeper System?

PathKeeper System is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Pathkeeper Surgical , Ltd.. The 510(k) number is K222355.

When did PathKeeper System receive FDA 510(k) clearance?

PathKeeper System received FDA 510(k) clearance on 2023-03-08, under 510(k) number K222355.

Who is the listed applicant for PathKeeper System?

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

What is the FDA product code for PathKeeper System?

The FDA product code for PathKeeper System is OLO.

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