Cleared Traditional

K930344 - SILICONE FOLEY CATHETER

K930344 is an FDA 510(k) clearance for SILICONE FOLEY CATHETER, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K930344 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
445d
Days
Class 2
Risk

K930344 is an FDA 510(k) clearance for the SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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: 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K930344

510(k) Number K930344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1993
Decision Date April 15, 1994
Days to Decision 445 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 131d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 92
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K930344.
ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K944381 · Regulatory & Marketing Services, Inc. · Nov 1994
GLASSMAN SILICONE CATHETER
K934895 · Axiom Medical, Inc. · Oct 1994
NORTA
K935630 · Beiersdorf, Inc. · Oct 1994
YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
K922821 · Yellow Springs Instrument Co., Inc. · Nov 1992
WRP FOLEYCATH
K903777 · Wembley Rubber Products (M) Sdn Bhd · Dec 1990
CURITY 100% SILICONE IRRIGATION FOLEY
K810691 · The Kendal Co. · Mar 1981