Cleared Traditional

K924646 - OVER THE GUIDEWIRE DILATATION SYSTEM (FDA 510(k) Clearance)

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

K924646 · Medovations, Inc. · Gastroenterology & Urology device
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Dec 1994
Decision
812d
Days
Class 2
Risk

K924646 is an FDA 510(k) clearance for the OVER THE GUIDEWIRE DILATATION SYSTEM. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Medovations, Inc. (Germantown, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 812 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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 Medovations, Inc. devices

Submission Details

510(k) Number K924646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1992
Decision Date December 05, 1994
Days to Decision 812 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
682d slower than avg
Panel avg: 130d · This submission: 812d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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.