Not Cleared Direct

DEN160037 - dermaPACE System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160037 · Sanuwave, Inc. · General & Plastic Surgery device
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Dec 2017
Decision
521d
Days
Class 2
Risk

DEN160037 is an FDA 510(k) submission (not cleared) for the dermaPACE System. Classified as Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (product code PZL), Class II - Special Controls.

Submitted by Sanuwave, Inc. (Alpharetta, US). The FDA issued a Not Cleared (DENG) decision on December 28, 2017 after a review of 521 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 521 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Sanuwave, Inc. devices

Submission Details

510(k) Number DEN160037 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 25, 2016
Decision Date December 28, 2017
Days to Decision 521 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
407d slower than avg
Panel avg: 114d · This submission: 521d
Pathway characteristics

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.