FDA 510(k)

Transvaginal Access Platform

Número K: K191294 · 2019-09-06

RequerenteApplied Medical Resources Corp.

Data da decisão2019-09-06

Código do produtoHEW

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transvaginal Access Platform is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191294. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Transvaginal Access Platform?

Transvaginal Access Platform is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K191294.

When did Transvaginal Access Platform receive FDA 510(k) clearance?

Transvaginal Access Platform received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191294.

Who is the listed applicant for Transvaginal Access Platform?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transvaginal Access Platform?

The FDA product code for Transvaginal Access Platform is HEW.

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Fonte oficial

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