Cleared Traditional

K941672 - URI-CATH CATHETER (FDA 510(k) Clearance)

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

K941672 · Gesco Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
41d
Days
Class 2
Risk

K941672 is an FDA 510(k) clearance for the URI-CATH CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 41 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 Gesco Intl., Inc. devices

Submission Details

510(k) Number K941672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date May 16, 1994
Days to Decision 41 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 130d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 70
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K941672.
Wellead® Hydrophilic Intermittent Catheter Ready to Use
K241734 · Well Lead Medical Co., Ltd. · Mar 2025
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · Convatec Limited · Jun 2022
Intermittent Catheter (Not Finalized)
K211436 · Hollister Incorporated · Jan 2022
Actreen Hi-Lite Intermittent Urinary Catheters
K192577 · B.Braun Medical, Inc. · May 2020