About This 510(k) Submission
K183461 is an FDA 510(k) clearance for the Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter, a Catheter, Urethral (Class II — Special Controls, product code GBM), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 8, 2019, 145 days after receiving the submission on December 14, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.