Cleared Traditional

K994109 - DETRUSAN 500

K994109 is an FDA 510(k) clearance for DETRUSAN 500, manufactured by Innovamed USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K994109 · Innovamed USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
241d
Days
Class 2
Risk

K994109 is an FDA 510(k) clearance for the DETRUSAN 500. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Innovamed USA, Inc. (Lehigh Acres, US). The FDA issued a Cleared decision on August 3, 2000 after a review of 241 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - 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 Innovamed USA, Inc. devices

FDA 510(k) Submission Details - K994109

510(k) Number K994109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date August 03, 2000
Days to Decision 241 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 130d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 54
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