Cleared Traditional

K972184 - RUSCH BRILLANT SILICONE FOLEY CATHETER

K972184 is an FDA 510(k) clearance for RUSCH BRILLANT SILICONE FOLEY CATHETER, manufactured by Rusch Intl.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K972184 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
212d
Days
Class 2
Risk

K972184 is an FDA 510(k) clearance for the RUSCH BRILLANT SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 212 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 Rusch Intl. devices

FDA 510(k) Submission Details - K972184

510(k) Number K972184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1997
Decision Date January 08, 1998
Days to Decision 212 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
81d slower than avg
Panel avg: 131d · This submission: 212d
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 100
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K972184.
RUSCH SILICONE FOLEY CATHETER
K980870 · Rusch, Inc. · Jun 1998
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
K980919 · Fortune Medical Instrument Corp. · Mar 1998
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
K974419 · Rusch, Inc. · Jan 1998
RUSCH BRILLANT BALLOON CATHETER
K971643 · Rusch Intl. · Oct 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
K971796 · Louisville Laboratories, Inc. · Aug 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT
K971801 · Louisville Laboratories, Inc. · Jul 1997