Surgitek

Surgitek — FDA 510(k) Submissions

Surgitek has submitted 29 FDA 510(k) premarket notifications since 1983, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stent, Ureteral, Dislodger, Stone, Flexible, Cystometric Gas (carbon-dioxide) On Hydraulic Device, Tissue Expander And Accessories, Monitor, Penile Tumescence . Use the specialty filter in the sidebar to narrow results.