Not Cleared Direct

DEN210012 - vPatch (FDA 510(k) Clearance)

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

DEN210012 · Virility Medical · Gastroenterology & Urology device
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Nov 2021
Decision
238d
Days
Class 2
Risk

DEN210012 is an FDA 510(k) submission (not cleared) for the vPatch. Classified as Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation (product code QRC), Class II - Special Controls.

Submitted by Virility Medical (Hod-Hasharon, IL). The FDA issued a Not Cleared (DENG) decision on November 23, 2021 after a review of 238 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5026 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Virility Medical devices

Submission Details

510(k) Number DEN210012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 30, 2021
Decision Date November 23, 2021
Days to Decision 238 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 130d · This submission: 238d
Pathway characteristics

Device Classification

Product Code QRC Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5026
Definition A Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation Is Intended To Be Used In Patients With Premature Ejaculation By Delivery Of Electrical Stimulation To The Perineal Muscles And Nerves.
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 Gastroenterology & Urology devices follow this clearance model.