Cleared Traditional

K962472 - RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER

K962472 is an FDA 510(k) clearance for RUSCH URODYNAMIC RECTAL BALLOON 2-WAY C..., manufactured by Rusch Intl.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K962472 · Rusch Intl. · Gastroenterology & Urology device
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Aug 1996
Decision
63d
Days
Class 2
Risk

K962472 is an FDA 510(k) clearance for the RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on August 27, 1996 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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

FDA 510(k) Submission Details - K962472

510(k) Number K962472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1996
Decision Date August 27, 1996
Days to Decision 63 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
68d faster than avg
Panel avg: 131d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 39
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K962472.
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
K113771 · Neurovision Medical Products, Inc. · Dec 2012
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
K974775 · Airtronic Services, Inc. · Feb 1998
URODYNAMIC ANALYSIS MODULE
K963330 · Synectics Medical, Inc. · Apr 1997
SCHUSTER DISPOSABLE BALLOON PROBE
K931175 · Sandhill Scientific, Inc. · Apr 1994
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383 · Synectics-Dantec · Jun 1993