510(k) K202112

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece by Storz Medical AG — Product Code PZL

K202112 is an FDA 510(k) premarket notification submitted by Storz Medical AG for the device "Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece". The FDA issued a decision of Substantially Equivalent on February 21, 2021. The device falls under product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers), a Class II device regulated under 21 CFR 878.4685. Storz Medical AG has at least 2 other 510(k) clearances on record.