FDA 510(k)

The EPAD 2 System

Número K: K182542 · 2019-02-22

Data da decisão2019-02-22

Código do produtoGWF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

The EPAD 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Safeop Surgical, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K182542. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The EPAD 2 System?

The EPAD 2 System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Safeop Surgical, Inc.. The 510(k) number is K182542.

When did The EPAD 2 System receive FDA 510(k) clearance?

The EPAD 2 System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K182542.

Who is the listed applicant for The EPAD 2 System?

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

What is the FDA product code for The EPAD 2 System?

The FDA product code for The EPAD 2 System is GWF.

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