510(k) K172278

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent by Cook Incorporated — Product Code GBM

K172278 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent". The FDA issued a decision of Substantially Equivalent on Nov 22, 2017. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Cook Incorporated has 174 other 510(k) clearances on record.