Cleared Traditional

K943851 - ALL SILICONE INTERMITTENT CATHETER

K943851 is the FDA 510(k) clearance for ALL SILICONE INTERMITTENT CATHETER by Rochester Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K943851 · Rochester Medical Corp. · Gastroenterology & Urology device
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Jan 1995
Decision
176d
Days
Class 2
Risk

K943851 is an FDA 510(k) clearance for the ALL SILICONE INTERMITTENT CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on January 31, 1995 after a review of 176 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 K943851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date January 31, 1995
Days to Decision 176 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
46d slower than avg
Panel avg: 130d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 36
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K943851.
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · Coloplast A/S · Oct 2012
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc. · Aug 2009
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · American Medical Systems, Inc. · Mar 1992
AUTOCATH(TM) SET
K910876 · Cook Urological, Inc. · May 1991
KENDALL CURITY URETHRAL CATHETERS
K892442 · The Kendal Co. · Jun 1989