510(k) K162060

Ahmed Glaucoma Valve by New World Medical, Inc. — Product Code KYF

K162060 is an FDA 510(k) premarket notification submitted by New World Medical, Inc. for the device "Ahmed Glaucoma Valve". The FDA issued a decision of Substantially Equivalent on October 24, 2016. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. New World Medical, Inc. has at least 10 other 510(k) clearances on record.