510(k) K202694

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) by Vycor Medical, Inc. — Product Code GZT

K202694 is an FDA 510(k) premarket notification submitted by Vycor Medical, Inc. for the device "Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)". The FDA issued a decision of Substantially Equivalent on January 14, 2021. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Vycor Medical, Inc. has at least 1 other 510(k) clearance on record.