Class Medical receives FDA 510(k) clearance for the TransUrethral Catheter Safety Valve
Class Medical Limited today announced that the United States Food and Drug Administration has granted 510(k) clearance (K260919) for the TransUrethral Catheter Safety Valve (TUCSV), clearing the device for marketing in the United States for use in adult patients.
The TUCSV is designed to prevent one of the most avoidable harms in routine clinical practice: inflation of a Foley catheter balloon while it is still in the urethra. The injuries that follow are painful, costly to treat, and almost entirely preventable. Every year, urethral catheters are inserted many millions of times across US healthcare settings, in emergency departments, operating theatres, wards and the community.
Clearance opens the largest single market for the device and follows Class Medical’s establishment of a US subsidiary earlier this year.
