Cleared Traditional

K993063 - RUSCH BRILLANT SILICONE FOLEY

K993063 is the FDA 510(k) clearance for RUSCH BRILLANT SILICONE FOLEY by Rusch Intl.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K993063 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
87d
Days
Class 2
Risk

K993063 is an FDA 510(k) clearance for the RUSCH BRILLANT SILICONE FOLEY. 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 December 9, 1999 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rusch Intl. devices

Submission Details

510(k) Number K993063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date December 09, 1999
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 58
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K993063.
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp. · Mar 2001
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
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
K990500 · The Kendal Co. · Sep 1999
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · Rusch Intl. · Jan 1998
RUSCH BRILLANT BALLOON CATHETER
K971643 · Rusch Intl. · Oct 1997