Cleared Traditional

K020714 - RUSCH FLONEIL

Also marketed or referenced as:
FLOCATH INTROGEL

K020714 is an FDA 510(k) clearance for RUSCH FLONEIL, manufactured by Rusch Intl.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K020714 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
118d
Days
Class 2
Risk

K020714 is an FDA 510(k) clearance for the RUSCH FLONEIL. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 118 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 Rusch Intl. devices

FDA 510(k) Submission Details - K020714

510(k) Number K020714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date July 01, 2002
Days to Decision 118 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
13d faster than avg
Panel avg: 131d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 60
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K020714.
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241 · Astra Tech, Inc. · Dec 2004
URINARY CATHETERS
K031409 · Promedic, Inc. · Jun 2003
SPEEDICATH
K023254 · Coloplast Corp. · Jan 2003
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc. · Aug 2001
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651 · Sc Hennig Enterprises Europe Srl · Dec 1999
UROLOGICAL CATHETER
K992137 · Apogee, Inc. · Sep 1999