Cleared Traditional

INNOVO (K192357) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192357 · Atlantic Therapeutics, Ltd. · Gastroenterology & Urology device
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Jan 2020
Decision
140d
Days
Class 2
Risk

K192357 is an FDA 510(k) clearance for the INNOVO. Classified as Cutaneous Electrode Stimulator For Urinary Incontinence (product code QAJ), Class II - Special Controls.

Submitted by Atlantic Therapeutics, Ltd. (Galway, IE). The FDA issued a Cleared decision on January 16, 2020 after a review of 140 days - within the typical 510(k) review window.

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 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Atlantic Therapeutics, Ltd. devices

Submission Details

510(k) Number K192357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2019
Decision Date January 16, 2020
Days to Decision 140 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 130d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.