Not Cleared Direct

DEN220073 - Revi System (FDA 510(k) Clearance)

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

DEN220073 · Bluewind Medical , Ltd. · Gastroenterology & Urology device
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Aug 2023
Decision
315d
Days
Class 2
Risk

DEN220073 is an FDA 510(k) submission (not cleared) for the Revi System. Classified as Implanted Tibial Electrical Urinary Continence Device (product code QXM), Class II - Special Controls.

Submitted by Bluewind Medical , Ltd. (Herzliya, IL). The FDA issued a Not Cleared (DENG) decision on August 16, 2023 after a review of 315 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5305 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 315 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 Bluewind Medical , Ltd. devices

Submission Details

510(k) Number DEN220073 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 05, 2022
Decision Date August 16, 2023
Days to Decision 315 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
185d slower than avg
Panel avg: 130d · This submission: 315d
Pathway characteristics

Device Classification

Product Code QXM Implanted Tibial Electrical Urinary Continence Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5305
Definition An Implanted Tibial Electrical Urinary Continence Device Is An Implanted Prescription Device That Receives Power From A Non-implanted External Power Source To Provide Electrical Stimulation Of The Tibial Nerve In Proximity To The Ankle. The Device Is Intended For The Treatment Of Overactive Bladder Related Symptoms Of Urge Urinary Incontinence, Urinary Urgency, Urinary Frequency And Nocturia.
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.