510(k) K163179

Onli Intermittent Catheter by Hollister Incorporated — Product Code GBM

K163179 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "Onli Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on January 26, 2017. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hollister Incorporated has at least 10 other 510(k) clearances on record.