Cleared Traditional

K140265 - ELECTRODE FOR URINARY INCONTINENCE

K140265 is an FDA 510(k) clearance for ELECTRODE FOR URINARY INCONTINENCE, manufactured by Guangzhou Finecure Medical Equipment Co.,Ltd. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K140265 · Guangzhou Finecure Medical Equipment Co.,Ltd · Gastroenterology & Urology device
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Jan 2015
Decision
354d
Days
Class 2
Risk

K140265 is an FDA 510(k) clearance for the ELECTRODE FOR URINARY INCONTINENCE. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Guangzhou Finecure Medical Equipment Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on January 23, 2015 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Guangzhou Finecure Medical Equipment Co.,Ltd devices

FDA 510(k) Submission Details - K140265

510(k) Number K140265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date January 23, 2015
Days to Decision 354 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 131d · This submission: 354d
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 87
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K140265.
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INTONEMV
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INTONEMV
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