Cleared Traditional

Rusch FloCath Quick 18 Fr. Coud? Hydrophilic Intermittent Catheter

K181979 · Teleflexmedical, Inc. · Gastroenterology & Urology
May 2019
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K181979 is an FDA 510(k) clearance for the Rusch FloCath Quick 18 Fr. Coud? Hydrophilic Intermittent Catheter, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 24, 2019, 303 days after receiving the submission on July 25, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K181979 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2018
Decision Date May 24, 2019
Days to Decision 303 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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