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FDA 510(k)

Zeolite Hemostatic Gauze

K-Number: K211570 · 2022-02-10

ApplicantHangzhou Zeo-Innov Life Technology Co., Ltd.
Decision Date2022-02-10
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Zeolite Hemostatic Gauze 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 2022-02-10 under 510(k) number K211570. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeolite Hemostatic Gauze?

Zeolite Hemostatic Gauze is a medical device that received FDA 510(k) clearance on 2022-02-10. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. The 510(k) number is K211570.

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

Zeolite Hemostatic Gauze received FDA 510(k) clearance on 2022-02-10, under 510(k) number K211570.

Who is the listed applicant for Zeolite Hemostatic Gauze?

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 Gauze?

The FDA product code for Zeolite Hemostatic Gauze 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.

K223495Zeolite Hemostatic Cotton

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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