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FDA 510(k)

QUIKCLOT HEMOSTATIC DRESSING

K-Number: K123387 · 2013-04-12

ApplicantZ-Medica, LLC
Decision Date2013-04-12
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

QUIKCLOT HEMOSTATIC DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Z-Medica, LLC. It received FDA 510(k) clearance on 2013-04-12 under 510(k) number K123387. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKCLOT HEMOSTATIC DRESSING?

QUIKCLOT HEMOSTATIC DRESSING is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Z-Medica, LLC. The 510(k) number is K123387.

When did QUIKCLOT HEMOSTATIC DRESSING receive FDA 510(k) clearance?

QUIKCLOT HEMOSTATIC DRESSING received FDA 510(k) clearance on 2013-04-12, under 510(k) number K123387.

Who is the listed applicant for QUIKCLOT HEMOSTATIC DRESSING?

The FDA 510(k) record lists Z-Medica, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIKCLOT HEMOSTATIC DRESSING?

The FDA product code for QUIKCLOT HEMOSTATIC DRESSING is QSY.

Related Clinical Trials

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.

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Other records listing Z-Medica, LLC as applicant

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.

K220971QuikClot Control+ Hemostatic DressingK200167QuikClot Control+K181641QuikClot Radial

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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