510(k) K183461

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter by Teleflexmedical, Inc. — Product Code GBM

K183461 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter". The FDA issued a decision of Substantially Equivalent (kit) on May 8, 2019. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.