Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Axiostat Gauze

K-Number: K222909 · 2023-04-07

ApplicantAdvamedica, Inc.
Decision Date2023-04-07
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Axiostat Gauze is the device name listed in this FDA 510(k) record. The listed applicant is Advamedica, Inc.. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K222909. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiostat Gauze?

Axiostat Gauze is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Advamedica, Inc.. The 510(k) number is K222909.

When did Axiostat Gauze receive FDA 510(k) clearance?

Axiostat Gauze received FDA 510(k) clearance on 2023-04-07, under 510(k) number K222909.

Who is the listed applicant for Axiostat Gauze?

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 Gauze?

The FDA product code for Axiostat Gauze 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 DressingK213198Ax-Surgi Surgical HemostatK202830Axiostat PatchK172324Axiostat Chitosan Hemostatic Dressing

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

View on FDA Database →

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

↑