Cleared Traditional

K910195 - BARD HYDROGEL-COATED FOLEY CATHETERS

K910195 is the FDA 510(k) clearance for BARD HYDROGEL-COATED FOLEY CATHETERS by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZC) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K910195 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
205d
Days
Class 2
Risk

K910195 is an FDA 510(k) clearance for the BARD HYDROGEL-COATED FOLEY CATHETERS. 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 K910195 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.