FDA 510(k)

Assut Filbloc Permanent Sutures

Número K: K171039 · 2017-08-29

Data da decisão2017-08-29

Código do produtoGAW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Assut Filbloc Permanent Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Assut Europe S.P.A.. It received FDA 510(k) clearance on 2017-08-29 under 510(k) number K171039. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Assut Filbloc Permanent Sutures?

Assut Filbloc Permanent Sutures is a medical device that received FDA 510(k) clearance on 2017-08-29. The listed applicant is Assut Europe S.P.A.. The 510(k) number is K171039.

When did Assut Filbloc Permanent Sutures receive FDA 510(k) clearance?

Assut Filbloc Permanent Sutures received FDA 510(k) clearance on 2017-08-29, under 510(k) number K171039.

Who is the listed applicant for Assut Filbloc Permanent Sutures?

The FDA 510(k) record lists Assut Europe S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Assut Filbloc Permanent Sutures?

The FDA product code for Assut Filbloc Permanent Sutures is GAW.

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