Cleared Traditional

EUROMEDICAL HAEMATURIA FOLEY CATHETER (K973076) - FDA 510(k) Clearance

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

K973076 · Unomedical Sdn Bhd · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
394d
Days
Class 2
Risk

K973076 is an FDA 510(k) clearance for the EUROMEDICAL HAEMATURIA FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Unomedical Sdn Bhd (Elfers, US). The FDA issued a Cleared decision on September 16, 1998 after a review of 394 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: Standard predicate-based submission. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K973076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date September 16, 1998
Days to Decision 394 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
264d slower than avg
Panel avg: 130d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K973076.
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
K002612 · C.R. Bard, Inc. · Sep 2002
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · C.R. Bard, Inc. · Jan 2001
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · C.R. Bard, Inc. · Dec 2000
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