FDA 510(k)

InnoSEAL Hemostatic Pad

Número K: K161013 · 2016-11-29

Data da decisão2016-11-29

Código do produtoQSY

DecisãoSubstantially Equivalent

Resumo do dispositivo

InnoSEAL Hemostatic Pad is the device name listed in this FDA 510(k) record. The listed applicant is Innotherapy, Inc.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K161013. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InnoSEAL Hemostatic Pad?

InnoSEAL Hemostatic Pad is a medical device that received FDA 510(k) clearance on 2016-11-29. The listed applicant is Innotherapy, Inc.. The 510(k) number is K161013.

When did InnoSEAL Hemostatic Pad receive FDA 510(k) clearance?

InnoSEAL Hemostatic Pad received FDA 510(k) clearance on 2016-11-29, under 510(k) number K161013.

Who is the listed applicant for InnoSEAL Hemostatic Pad?

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

What is the FDA product code for InnoSEAL Hemostatic Pad?

The FDA product code for InnoSEAL Hemostatic Pad is QSY.

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