Cleared Traditional

URI-CATH CATHETER

K941672 · Gesco Intl., Inc. · Gastroenterology & Urology
May 1994
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K941672 is an FDA 510(k) clearance for the URI-CATH CATHETER, a Catheter, Urethral (Class II — Special Controls, product code GBM), submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on May 16, 1994, 41 days after receiving the submission on April 5, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K941672 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GBM — Catheter, Urethral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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