Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece

FDA 510(k) K202112 · Storz Medical AG

Substantially Equivalent

510(k) numberK202112

Submission

Device name
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
Applicant
Storz Medical AG
Tagerwilen, CH
Received
July 30, 2020
Decision date
February 21, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PZL – Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4685
Specialty
General, Plastic Surgery

Treatment of diabetic foot ulcers

Other 510(k)s with product code PZL

510(k)DeviceApplicantDecision
K243279DOLORCLAST Focused Shock WavesPZL · Traditional E.M.S Electro Medical Systems S.A08/13/2025SE
K250779CS-Pro MEDPZL · Traditional Curative Sound Therapeutics07/02/2025SE
K233937OW100SPZL · Traditional Softwave/Trt, LLC07/09/2024SE
K231710OW100SPZL · Traditional Softwave/Trt, LLC09/01/2023SE
K200926OrthoGold 100PZL · Traditional Tissue Regeneration Technologies, LLC08/28/2020SE
K191961OrthoGoldPZL · Traditional Tissue Regeneration Technologies11/26/2019SE

More from Tissue Regeneration Technologies

510(k)DeviceDecision
K203710Storz Medical MAGNETOLITH Muscle StimulatorIPF · Traditional 05/03/2021SE
K173692D-Actor 200 Vibration Massage SystemISA · Traditional 04/13/2018SE

Questions and answers

When was Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece cleared by the FDA?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (K202112) received a 510(k) decision of Substantially Equivalent on February 21, 2021, 206 days after the submission was received.

What is the product code of K202112?

The FDA product code is PZL – Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers, a Class II (moderate risk) device regulated under 21 CFR 878.4685.