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FDA 510(k)

Zeolite Hemostatic Cotton

K-Number: K223495 · 2023-05-02

ApplicantHangzhou Zeo-Innov Life Technology Co., Ltd.
Decision Date2023-05-02
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Zeolite Hemostatic Cotton is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K223495. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeolite Hemostatic Cotton?

Zeolite Hemostatic Cotton is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. The 510(k) number is K223495.

When did Zeolite Hemostatic Cotton receive FDA 510(k) clearance?

Zeolite Hemostatic Cotton received FDA 510(k) clearance on 2023-05-02, under 510(k) number K223495.

Who is the listed applicant for Zeolite Hemostatic Cotton?

The FDA 510(k) record lists Hangzhou Zeo-Innov Life Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zeolite Hemostatic Cotton?

The FDA product code for Zeolite Hemostatic Cotton is QSY.

Other records listing Hangzhou Zeo-Innov Life Technology Co., Ltd. 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.

K211570Zeolite Hemostatic Gauze

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.

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