FDA Product Code QWS: Foam Or Gel Chemical Sterilant/high Level Disinfectant
A Foam Or Gel Chemical Sterilant/high Level Disinfectant Is A Germicide In The Form Of A Foam Or Gel That Is Intended For Use As The Terminal Step In High Level Disinfection Of Medical Devices Prior To Patient Use.
Leading manufacturers include Tristel Solutions Limited and Tristel Solutions , Ltd..
FDA 510(k) Cleared Foam Or Gel Chemical Sterilant/high Level Disinfectant Devices (Product Code QWS)
About Product Code QWS - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QWS since 2023, with 1 receiving FDA clearance (average review time: 290 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QWS have taken an average of 241 days to reach a decision - down from 338 days historically, suggesting improved FDA processing for this classification.
QWS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →