510(k) K222279

Rusch Intermittent Urethral Catheters by Teleflex Medical — Product Code EZC

K222279 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Rusch Intermittent Urethral Catheters". The FDA issued a decision of Substantially Equivalent on August 29, 2022. The device falls under product code EZC (Catheter, Coude), a Class II device regulated under 21 CFR 876.5130. Teleflex Medical has at least 10 other 510(k) clearances on record.