FDA 510(k)

LaparoLight Veress Needle

Número K: K171139 · 2017-05-18

Data da decisão2017-05-18

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

LaparoLight Veress Needle is the device name listed in this FDA 510(k) record. The listed applicant is Buffalo Filter, LLC. It received FDA 510(k) clearance on 2017-05-18 under 510(k) number K171139. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LaparoLight Veress Needle?

LaparoLight Veress Needle is a medical device that received FDA 510(k) clearance on 2017-05-18. The listed applicant is Buffalo Filter, LLC. The 510(k) number is K171139.

When did LaparoLight Veress Needle receive FDA 510(k) clearance?

LaparoLight Veress Needle received FDA 510(k) clearance on 2017-05-18, under 510(k) number K171139.

Who is the listed applicant for LaparoLight Veress Needle?

The FDA 510(k) record lists Buffalo Filter, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LaparoLight Veress Needle?

The FDA product code for LaparoLight Veress Needle is HIF.

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