FDA 510(k)

U-Blade Veress Needle

Número K: K162648 · 2016-12-12

RequerenteTianjin Uwell Medical Device Manufacturing Co., Ltd.

Data da decisão2016-12-12

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

U-Blade Veress Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162648. 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 U-Blade Veress Needle?

U-Blade Veress Needle is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The 510(k) number is K162648.

When did U-Blade Veress Needle receive FDA 510(k) clearance?

U-Blade Veress Needle received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162648.

Who is the listed applicant for U-Blade Veress Needle?

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

What is the FDA product code for U-Blade Veress Needle?

The FDA product code for U-Blade Veress Needle is HIF.

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