Cleared Traditional

HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS (K910197) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910197 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
205d
Days
Class 2
Risk

K910197 is an FDA 510(k) clearance for the HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS. Classified as Catheter, Coude (product code EZC), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 9, 1991 after a review of 205 days - an extended review 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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K910197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1991
Decision Date August 09, 1991
Days to Decision 205 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 130d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZC Catheter, Coude
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 - EZC Catheter, Coude

Devices cleared under the same product code (EZC) and FDA review panel - the closest regulatory comparables to K910197.
Rusch Intermittent Urethral Catheters
K222279 · Teleflex Medical · Aug 2022
Rusch Intermittent Urethral Catheters
K173596 · Teleflex Medical · Jan 2018
BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
K913341 · C.R. Bard, Inc. · Jan 1992
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
K910846 · C.R. Bard, Inc. · Aug 1991
BARD HYDROGEL-COATED FOLEY CATHETERS
K910195 · C.R. Bard, Inc. · Aug 1991