Cleared Traditional

K103698 - TENSCARE ITOUCH SURE MODEL ITS

K103698 is an FDA 510(k) clearance for TENSCARE ITOUCH SURE MODEL ITS, manufactured by Tenscare, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K103698 · Tenscare, Ltd. · Gastroenterology & Urology device
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Jun 2011
Decision
183d
Days
Class 2
Risk

K103698 is an FDA 510(k) clearance for the TENSCARE ITOUCH SURE MODEL ITS. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Tenscare, Ltd. (Epsom, Surrey, GB). The FDA issued a Cleared decision on June 21, 2011 after a review of 183 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 Tenscare, Ltd. devices

FDA 510(k) Submission Details - K103698

510(k) Number K103698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2010
Decision Date June 21, 2011
Days to Decision 183 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
52d slower than avg
Panel avg: 131d · This submission: 183d
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
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