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FDA 510(k)

Axiostat Chitosan Hemostatic Dressing

K-Number: K172324 · 2018-02-23

ApplicantAdvamedica, Inc.
Decision Date2018-02-23
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Axiostat Chitosan Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advamedica, Inc.. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K172324. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiostat Chitosan Hemostatic Dressing?

Axiostat Chitosan Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Advamedica, Inc.. The 510(k) number is K172324.

When did Axiostat Chitosan Hemostatic Dressing receive FDA 510(k) clearance?

Axiostat Chitosan Hemostatic Dressing received FDA 510(k) clearance on 2018-02-23, under 510(k) number K172324.

Who is the listed applicant for Axiostat Chitosan Hemostatic Dressing?

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

What is the FDA product code for Axiostat Chitosan Hemostatic Dressing?

The FDA product code for Axiostat Chitosan Hemostatic Dressing is QSY.

Other records listing Advamedica, Inc. 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.

K212766Maxiocel Chitosan Wound DressingK222909Axiostat GauzeK213198Ax-Surgi Surgical HemostatK202830Axiostat Patch

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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