FDA Product Code QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
To Temporarily Control Bleeding And Cover External Wounds.
Leading manufacturers include Cresilon, Inc., Starch Medical, Inc. and Advamedica, Inc..
FDA 510(k) Cleared Hemostatic Wound Dressing Without Thrombin Or Other Biologics Devices (Product Code QSY)
About Product Code QSY - Regulatory Context
510(k) Submission Activity
127 total 510(k) submissions under product code QSY since 1990, with 127 receiving FDA clearance (average review time: 176 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
FDA review times for QSY submissions have been consistent, averaging 186 days recently vs 175 days historically.
QSY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →