Cleared Traditional

CATHEJELL S STERILE LUBRICATING JELLY (K935548) - FDA 510(k) Clearance

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

K935548 · Pharmazeutische Fabrik Montavit GmbH · Gastroenterology & Urology device
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Mar 1994
Decision
133d
Days
Class 2
Risk

K935548 is an FDA 510(k) clearance for the CATHEJELL S STERILE LUBRICATING JELLY. Classified as Jelly, Lubricating, For Transurethral Surgical Instrument (product code FHX), Class II - Special Controls.

Submitted by Pharmazeutische Fabrik Montavit GmbH (Wilton, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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.

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Submission Details

510(k) Number K935548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date March 30, 1994
Days to Decision 133 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
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FHX Jelly, Lubricating, For Transurethral Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.