Cleared Abbreviated

K993840 - BARD UROFORCE BALLOON DILATION CATHETER

K993840 is the FDA 510(k) clearance for BARD UROFORCE BALLOON DILATION CATHETER by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

K993840 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
80d
Days
Class 2
Risk

K993840 is an FDA 510(k) clearance for the BARD UROFORCE BALLOON DILATION CATHETER. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 31, 2000 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K993840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date January 31, 2000
Days to Decision 80 days
Submission Type Abbreviated
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
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K993840.
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
U-BALLOON DILATION CATHETER
K050875 · C.R. Bard, Inc. · May 2005
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · Cook Urological, Inc. · Apr 2004
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
K990072 · Cook Urological, Inc. · Mar 1999
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · Boston Scientific Corp · Apr 1998
ASCEND BALLOON DAILATION CATHETER
K970041 · Cook Urological, Inc. · Mar 1997