Cleared Traditional

DOVER RED RUBBER ROBINSON CATHETER

K041243 · Tyco Healthcare · Gastroenterology & Urology
Jul 2004
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K041243 is an FDA 510(k) clearance for the DOVER RED RUBBER ROBINSON CATHETER, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on July 7, 2004, 57 days after receiving the submission on May 11, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K041243 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2004
Decision Date July 07, 2004
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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