Cleared Traditional

K945806 - SILICATH ALL SILICONE FOLEY CATHETER

K945806 is an FDA 510(k) clearance for SILICATH ALL SILICONE FOLEY CATHETER, manufactured by Unomedical Sdn Bhd. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K945806 · Unomedical Sdn Bhd · Gastroenterology & Urology device
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Mar 1995
Decision
113d
Days
Class 2
Risk

K945806 is an FDA 510(k) clearance for the SILICATH ALL SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Unomedical Sdn Bhd (Sungai Petani, Kedah, MY). The FDA issued a Cleared decision on March 21, 1995 after a review of 113 days - within the typical 510(k) review window.

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 Unomedical Sdn Bhd devices

FDA 510(k) Submission Details - K945806

510(k) Number K945806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date March 21, 1995
Days to Decision 113 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
18d faster than avg
Panel avg: 131d · This submission: 113d
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 93
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K945806.
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · Baxter Healthcare Corp · Jun 1995
SILICONE FOLEY CATHETER
K951106 · Cook Urological, Inc. · May 1995
SILASTIC BRAND FOLEY CATHETER
K951103 · C.R. Bard, Inc. · Apr 1995
ORION ALL SILICONE FOLEY CATHETER
K944382 · Regulatory & Marketing Services, Inc. · Dec 1994
ORION ALL SILICONE ELASTOMER COATED CATHETER
K944376 · Regulatory & Marketing Services, Inc. · Nov 1994
ORION FOLEY CATHETER
K944380 · Regulatory & Marketing Services, Inc. · Nov 1994