FDA 510(k)

SUNTOUCH TOPICAL HEMOSTATIC DRESSING

K-Number: K112800 · 2012-05-23

ApplicantHuizhou Foryou Medical Devices Co., Ltd.

Decision Date2012-05-23

Product CodeQSY

DecisionSubstantially Equivalent

Device Summary

SUNTOUCH TOPICAL HEMOSTATIC DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2012-05-23 under 510(k) number K112800. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNTOUCH TOPICAL HEMOSTATIC DRESSING?

SUNTOUCH TOPICAL HEMOSTATIC DRESSING is a medical device that received FDA 510(k) clearance on 2012-05-23. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K112800.

When did SUNTOUCH TOPICAL HEMOSTATIC DRESSING receive FDA 510(k) clearance?

SUNTOUCH TOPICAL HEMOSTATIC DRESSING received FDA 510(k) clearance on 2012-05-23, under 510(k) number K112800.

Who is the listed applicant for SUNTOUCH TOPICAL HEMOSTATIC DRESSING?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNTOUCH TOPICAL HEMOSTATIC DRESSING?

The FDA product code for SUNTOUCH TOPICAL HEMOSTATIC DRESSING is QSY.

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Related Devices (Code: QSY)

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 Limited K250319MFUSE (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.