510(k) K143462

AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) by Benq Materials Corporation — Product Code QSY

K143462 is an FDA 510(k) premarket notification submitted by Benq Materials Corporation for the device "AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)". The FDA issued a decision of Substantially Equivalent on May 8, 2015. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Benq Materials Corporation has at least 3 other 510(k) clearances on record.