Cleared Traditional

K033477 - HYDROPHILIC-ANTIBACTERIAL INTERMITTENT ...

K033477 is the FDA 510(k) clearance for HYDROPHILIC-ANTIBACTERIAL INTERMITTENT ... by Rochester Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code MJC) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K033477 · Rochester Medical Corp. · Gastroenterology & Urology device
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Jun 2004
Decision
220d
Days
Class 2
Risk

K033477 is an FDA 510(k) clearance for the HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED.... Classified as Catheter, Urological (antimicrobial) And Accessories (product code MJC), Class II - Special Controls.

Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 220 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Rochester Medical Corp. devices

Submission Details

510(k) Number K033477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2003
Decision Date June 10, 2004
Days to Decision 220 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
90d slower than avg
Panel avg: 130d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJC Catheter, Urological (antimicrobial) And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - MJC Catheter, Urological (antimicrobial) And Accessories

Devices cleared under the same product code (MJC) and FDA review panel - the closest regulatory comparables to K033477.
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K983101 · C.R. Bard, Inc. · Nov 1998
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K910318 · C.R. Bard, Inc. · Aug 1994