Cleared Traditional

K964738 - ELPHA 2000 CONTI

K964738 is an FDA 510(k) clearance for ELPHA 2000 CONTI, manufactured by Dan Med, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K964738 · Dan Med, Inc. · Gastroenterology & Urology device
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Aug 1997
Decision
274d
Days
Class 2
Risk

K964738 is an FDA 510(k) clearance for the ELPHA 2000 CONTI. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Dan Med, Inc. (Boulder, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 274 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 Dan Med, Inc. devices

FDA 510(k) Submission Details - K964738

510(k) Number K964738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1996
Decision Date August 14, 1997
Days to Decision 274 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 130d · This submission: 274d
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 54
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K964738.
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INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · Empi · Jun 1997
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K971541 · Hollister, Inc. · Jun 1997