FDA 510(k)

Polydioxanone Surgical Scaffold

Número K: K181094 · 2018-08-02

Data da decisão2018-08-02

Código do produtoFTL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Polydioxanone Surgical Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Lntegra Lifesciences. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181094. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Polydioxanone Surgical Scaffold?

Polydioxanone Surgical Scaffold is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Lntegra Lifesciences. The 510(k) number is K181094.

When did Polydioxanone Surgical Scaffold receive FDA 510(k) clearance?

Polydioxanone Surgical Scaffold received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181094.

Who is the listed applicant for Polydioxanone Surgical Scaffold?

The FDA 510(k) record lists Lntegra Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polydioxanone Surgical Scaffold?

The FDA product code for Polydioxanone Surgical Scaffold is FTL.

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