About This 510(k) Submission
K202112 is an FDA 510(k) clearance for the Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece, a Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (Class II — Special Controls, product code PZL), submitted by Storz Medical AG (Tagerwilen, CH). The FDA issued a Cleared decision on February 21, 2021, 206 days after receiving the submission on July 30, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4685.