Cleared Traditional

K070331 - UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES

K070331 is an FDA 510(k) clearance for UROSTYM BIOFEEDBACK AND STIMULATION DEV..., manufactured by Laborie Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K070331 · Laborie Medical Technologies · Gastroenterology & Urology device
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May 2007
Decision
88d
Days
Class 2
Risk

K070331 is an FDA 510(k) clearance for the UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Laborie Medical Technologies (Williston, US). The FDA issued a Cleared decision on May 4, 2007 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laborie Medical Technologies devices

FDA 510(k) Submission Details - K070331

510(k) Number K070331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2007
Decision Date May 04, 2007
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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
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