Not Cleared Direct

DEN170049 - Innovo (FDA 510(k) Clearance)

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

DEN170049 · Bio-Medical Research, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
414d
Days
Class 2
Risk

DEN170049 is an FDA 510(k) submission (not cleared) for the Innovo. Classified as Cutaneous Electrode Stimulator For Urinary Incontinence (product code QAJ), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Not Cleared (DENG) decision on November 6, 2018 after a review of 414 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5330 - 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 414 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 Bio-Medical Research, Ltd. devices

Submission Details

510(k) Number DEN170049 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 18, 2017
Decision Date November 06, 2018
Days to Decision 414 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
284d slower than avg
Panel avg: 130d · This submission: 414d
Pathway characteristics

Device Classification

Product Code QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5330
Definition A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence.
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.