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

FDA 510(k) K202694 · Vycor Medical, Inc.

Substantially Equivalent

510(k) numberK202694

Submission

Device name
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
Applicant
Vycor Medical, Inc.
Boca Raton, FL, US
Received
September 16, 2020
Decision date
January 14, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZT – Retractor, Self-Retaining, For Neurosurgery
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4800
Specialty
Neurology

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K180610Geister retractor for neuro - and spine surgeryGZT · Traditional Geister Medizin Technik GmbH08/29/2018SE
K172433NICO BrainPathGZT · Special Nico Corporation09/07/2017SE
K161680MEDICON Spinal Spreading SystemsGZT · Traditional Medicon EG03/24/2017SE
K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional Tedan Surgical Innovations, LLC03/20/2017SE
K161004Self-retaining RetractorGZT · Traditional Fetzer Medical GmbH & Co. KG09/09/2016SE
K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional Nico Corporation06/12/2015SE
K120691Brain PortGZT · Traditional Nico Corporation06/05/2012SE
K113273Spotlight Access SystemGZT · Traditional Johnson & Johnson01/27/2012SE

More from Johnson & Johnson

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Questions and answers

When was Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) cleared by the FDA?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) (K202694) received a 510(k) decision of Substantially Equivalent on January 14, 2021, 120 days after the submission was received.

What is the product code of K202694?

The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.