Cleared Traditional

ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (K010365) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K010365 · Personal Products Co. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2001
Decision
82d
Days
Class 1
Risk

K010365 is an FDA 510(k) clearance for the ORTHO CONTROL FEMALE URINARY CONTROL DEVICE. Classified as External Urethral Occluder, Urinary Incontinence-control, Female (product code MNG), Class I - General Controls.

Submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on April 30, 2001 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - 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 Personal Products Co. devices

Submission Details

510(k) Number K010365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2001
Decision Date April 30, 2001
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNG External Urethral Occluder, Urinary Incontinence-control, Female
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
Definition Intended To Prevent Or Decrease Episodes Of Urine Leakage In Women With Stress Incontinence. Occluder Is Applied To Urinary Meatus Through Suction Or Tape, Which Creates A Barrier For Urine Leakage. Occluding Device Such As A Cap, Suction Cup, Or Foam Pad. May Include Adhesive Gel Or Ointment.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.