Cleared Traditional

K990041 - UROSTYM BIOFEEDBACK AND STIMULATION PROBES

K990041 is an FDA 510(k) clearance for UROSTYM BIOFEEDBACK AND STIMULATION PROBES, manufactured by Laborie Medical Tech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K990041 · Laborie Medical Tech Corp. · Gastroenterology & Urology device
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Aug 1999
Decision
211d
Days
Class 2
Risk

K990041 is an FDA 510(k) clearance for the UROSTYM BIOFEEDBACK AND STIMULATION PROBES. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Laborie Medical Tech Corp. (Williston, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 211 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 Laborie Medical Tech Corp. devices

FDA 510(k) Submission Details - K990041

510(k) Number K990041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1999
Decision Date August 05, 1999
Days to Decision 211 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 131d · This submission: 211d
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 82
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K990041.
DETRUSAN 500
K994109 · Innovamed USA, Inc. · Aug 2000
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
K993976 · The Prometheus Group · Feb 2000
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
K993721 · Laborie Medical Tech Corp. · Nov 1999
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · Hollister, Inc. · Mar 1999
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
K973096 · Neotonus, Inc. · Jun 1998