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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 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.

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. 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.

Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.

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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