Cleared Traditional

K202112 - Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202112 · Storz Medical AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
206d
Days
Class 2
Risk

K202112 is an FDA 510(k) clearance for the Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece. Classified as Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (product code PZL), Class II - Special Controls.

Submitted by Storz Medical AG (Tagerwilen, CH). The FDA issued a Cleared decision on February 21, 2021 after a review of 206 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4685 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Storz Medical AG devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 114d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4685
Definition Treatment Of Diabetic Foot Ulcers
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Biomed Research, Inc.
Michael Dayton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.