FDA 510(k)

Episealer Patellofemoral System

Número K: K221048 · 2022-12-23

Data da decisão2022-12-23

Código do produtoKRR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Episealer Patellofemoral System is the device name listed in this FDA 510(k) record. The listed applicant is Episurf Medical, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221048. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Episealer Patellofemoral System?

Episealer Patellofemoral System is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Episurf Medical, Inc.. The 510(k) number is K221048.

When did Episealer Patellofemoral System receive FDA 510(k) clearance?

Episealer Patellofemoral System received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221048.

Who is the listed applicant for Episealer Patellofemoral System?

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

What is the FDA product code for Episealer Patellofemoral System?

The FDA product code for Episealer Patellofemoral System is KRR.

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