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FDA 510(k)

Axiostat Patch

K-Number: K202830 · 2021-04-15

ApplicantAdvamedica, Inc.
Decision Date2021-04-15
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Axiostat Patch is the device name listed in this FDA 510(k) record. The listed applicant is Advamedica, Inc.. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K202830. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiostat Patch?

Axiostat Patch is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Advamedica, Inc.. The 510(k) number is K202830.

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

Axiostat Patch received FDA 510(k) clearance on 2021-04-15, under 510(k) number K202830.

Who is the listed applicant for Axiostat Patch?

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 Patch?

The FDA product code for Axiostat Patch 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.

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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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