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FDA 510(k)

InnoSEAL Hemostatic Pad

K-Number: K161013 · 2016-11-29

ApplicantInnotherapy, Inc.
Decision Date2016-11-29
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

InnoSEAL Hemostatic Pad is a medical device manufactured by Innotherapy, Inc.. It received FDA 510(k) clearance on 2016-11-29 under approval number K161013. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InnoSEAL Hemostatic Pad?

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

When was InnoSEAL Hemostatic Pad approved by the FDA?

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

What company makes InnoSEAL Hemostatic Pad?

InnoSEAL Hemostatic Pad is manufactured by Innotherapy, Inc..

What is the FDA product code for InnoSEAL Hemostatic Pad?

The FDA product code for InnoSEAL Hemostatic Pad is QSY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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