510(k) K191633

Infyna Chic by Hollister Incorporated — Product Code GBM

K191633 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "Infyna Chic". The FDA issued a decision of Substantially Equivalent on July 19, 2019. 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.