Cleared Abbreviated

BARD UROFORCE BALLOON DILATION CATHETER (K993840) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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 55
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K993840.
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910 · Urotronic, Inc. · May 2025
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
K220781 · Allwin Medical Devices, Inc. · May 2023
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · Coloplast Corp. · Jun 2020
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019
Ureteral Dilator Sets, Ureteral Dilators
K173654 · Cook Incorporated · Jul 2018
Safety Wire Guide Introducer
K180756 · Cook Incorporated · May 2018