Cleared Traditional

Vycor Medical Viewsite Brain Access System (?VBAS?) and VBAS with Alignment Clip (?VBAS AC?) (together the ?VBAS Family?)

K202694 · Vycor Medical, Inc. · Neurology

Jan 2021

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K202694 is an FDA 510(k) clearance for the Vycor Medical Viewsite Brain Access System (?VBAS?) and VBAS with Alignment Clip (?VBAS AC?) (together the ?VBAS Family?), a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Vycor Medical, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 14, 2021, 120 days after receiving the submission on September 16, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number	K202694 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2020
Decision Date	January 14, 2021
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF