Cleared Traditional

WELCON HUE-VU URINARY DRAINAGE BAG

K971764 · Welcon, Inc. · Gastroenterology & Urology
Jul 1997
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K971764 is an FDA 510(k) clearance for the WELCON HUE-VU URINARY DRAINAGE BAG, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on July 29, 1997, 77 days after receiving the submission on May 13, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K971764 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1997
Decision Date July 29, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNX — Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5250

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