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FDA 510(k)

S.E.A.L. Hemostatic Wound Spray

K-Number: K210751 · 2023-02-02

ApplicantBc3 Technologies, Inc.
Decision Date2023-02-02
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

S.E.A.L. Hemostatic Wound Spray is the device name listed in this FDA 510(k) record. The listed applicant is Bc3 Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) 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. The listed applicant is Bc3 Technologies, Inc.. The 510(k) number is K210751.

When did S.E.A.L. Hemostatic Wound Spray receive FDA 510(k) clearance?

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

Who is the listed applicant for S.E.A.L. Hemostatic Wound Spray?

The FDA 510(k) record lists Bc3 Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 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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