Cleared Traditional

URGENT PC STIMULATOR (K101847) - FDA 510(k) Clearance

Also marketed or referenced as:
URGENT PC LEAD SET

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

K101847 · Uroplasty, Inc. · Gastroenterology & Urology device
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Oct 2010
Decision
112d
Days
Class 2
Risk

K101847 is an FDA 510(k) clearance for the URGENT PC STIMULATOR. Classified as Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence (product code NAM), Class II - Special Controls.

Submitted by Uroplasty, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 21, 2010 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5310 - 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 Uroplasty, Inc. devices

Submission Details

510(k) Number K101847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date October 21, 2010
Days to Decision 112 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
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAM Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5310
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.