Cleared Traditional

K891007 - NONIMPLANTED ELECTRICAL CONTINENCE DEVICE

K891007 is the FDA 510(k) clearance for NONIMPLANTED ELECTRICAL CONTINENCE DEVICE by Tridak Division of Indicon, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KPI) cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K891007 · Tridak Division of Indicon, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
465d
Days
Class 2
Risk

K891007 is an FDA 510(k) clearance for the NONIMPLANTED ELECTRICAL CONTINENCE DEVICE. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Tridak Division of Indicon, Inc. (Williston, US). The FDA issued a Cleared decision on June 7, 1990 after a review of 465 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Tridak Division of Indicon, Inc. devices

Submission Details

510(k) Number K891007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date June 07, 1990
Days to Decision 465 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 130d · This submission: 465d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K891007.
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