510(k) K201743

ClarifEye R1.0, ClarifEye Needle by Philips Medical Systems Nederlands B.V. — Product Code OWB

K201743 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederlands B.V. for the device "ClarifEye R1.0, ClarifEye Needle". The FDA issued a decision of Substantially Equivalent on February 23, 2021. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems Nederlands B.V. has at least 7 other 510(k) clearances on record.