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FDA 510(k)

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

K-Number: K240097 · 2024-05-22

ApplicantUshare Medical, Inc.
Decision Date2024-05-22
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is the device name listed in this FDA 510(k) record. The listed applicant is Ushare Medical, Inc.. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K240097. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)?

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Ushare Medical, Inc.. The 510(k) number is K240097.

When did Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) receive FDA 510(k) clearance?

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) received FDA 510(k) clearance on 2024-05-22, under 510(k) number K240097.

Who is the listed applicant for Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)?

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

What is the FDA product code for Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)?

The FDA product code for Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is QSY.

Other records listing Ushare Medical, 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.K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.

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.

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