Cleared Traditional

Rusch Silicone Foley Catheter

K161770 · Teleflexmedical, Inc. · Gastroenterology & Urology
May 2017
Decision
311d
Days
Class 2
Risk

About This 510(k) Submission

K161770 is an FDA 510(k) clearance for the Rusch Silicone Foley Catheter, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on May 5, 2017, 311 days after receiving the submission on June 28, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K161770 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2016
Decision Date May 05, 2017
Days to Decision 311 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZL — Catheter, Retention Type, Balloon
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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