FDA 510(k)

ClearPetra Suction-Evacuation Sheath

Número K: K161110 · 2016-10-12

Data da decisão2016-10-12

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ClearPetra Suction-Evacuation Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K161110. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClearPetra Suction-Evacuation Sheath?

ClearPetra Suction-Evacuation Sheath is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K161110.

When did ClearPetra Suction-Evacuation Sheath receive FDA 510(k) clearance?

ClearPetra Suction-Evacuation Sheath received FDA 510(k) clearance on 2016-10-12, under 510(k) number K161110.

Who is the listed applicant for ClearPetra Suction-Evacuation Sheath?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPetra Suction-Evacuation Sheath?

The FDA product code for ClearPetra Suction-Evacuation Sheath is FED.

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Dispositivos Relacionados (Código: FED)

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Fonte oficial

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