510(k) K101900

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH by Hakki Medical Technologies, Inc. — Product Code GBM

K101900 is an FDA 510(k) premarket notification submitted by Hakki Medical Technologies, Inc. for the device "HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH". The FDA issued a decision of Substantially Equivalent on February 7, 2011. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hakki Medical Technologies, Inc. has at least 1 other 510(k) clearance on record.