FDA 510(k)

S.E.A.L. Hemostatic Wound Spray

K-Number: K210751 · 2023-02-02

Decision Date2023-02-02

Product CodeQSY

DecisionSubstantially Equivalent

Device Summary

S.E.A.L. Hemostatic Wound Spray is a medical device manufactured by Bc3 Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-02 under approval number K210751. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S.E.A.L. Hemostatic Wound Spray?

S.E.A.L. Hemostatic Wound Spray is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Bc3 Technologies, Inc.. The 510(k) number is K210751.

When was S.E.A.L. Hemostatic Wound Spray approved by the FDA?

S.E.A.L. Hemostatic Wound Spray received FDA 510(k) clearance on 2023-02-02, under approval number K210751.

What company makes S.E.A.L. Hemostatic Wound Spray?

S.E.A.L. Hemostatic Wound Spray is manufactured by Bc3 Technologies, Inc..

What is the FDA product code for S.E.A.L. Hemostatic Wound Spray?

The FDA product code for S.E.A.L. Hemostatic Wound Spray is QSY.

Related Clinical Trials

NCT04996173 Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis) ACTIVE_NOT_RECRUITING

Related Devices (Code: QSY)

K161013InnoSEAL Hemostatic PadInnotherapy, Inc. K160679WoundClot9Core Scientific Creation , Ltd. K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc. K160578Nustat XRBeeken Biomedical, LLC K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. K161274Bondiloxs Topical Hemostatic GranulesMedtrade Products , Ltd.

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.