Cleared Traditional

K963993 - RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET

K963993 is an FDA 510(k) clearance for RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET, manufactured by Rusch, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K963993 · Rusch, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
74d
Days
Class 2
Risk

K963993 is an FDA 510(k) clearance for the RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 74 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, Inc. devices

FDA 510(k) Submission Details - K963993

510(k) Number K963993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date December 17, 1996
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCM Device Classification - Class 2, Special Controls

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
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 - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 29
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K963993.
RUSCH MMG/O'NEIL CATHETER
K010420 · Rusch, Inc. · May 2001
MENTOR SELF-CATH CLOSED SYSTEM
K003873 · Mentor Corp. · Mar 2001
SELF CATH SET/SAFETY CATH
K983010 · Rusch Intl. · Feb 1999
UNIVERSAL DRAINAGE TRAY
K961442 · Customed, Inc. · May 1996
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479 · Trinity Laboratories, Inc. · Jun 1995
UROLOGICAL CATHETER & ACCESSORIES
K951178 · Deroyal Industries, Inc. · Apr 1995