K202112 is an FDA 510(k) clearance for the Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4685. Treatment Of Diabetic Foot Ulcers.
| 510(k) Number | K202112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2020 |
| Decision Date | February 21, 2021 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PZL - Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4685 |
| Definition | Treatment Of Diabetic Foot Ulcers |