FDA.reportPublic FDA data

510(k) K202694

Device
Vycor Medical Viewsite Brain Access System (“VBAS”) And VBAS With Alignment Clip (“VBAS AC”) (together The “VBAS Family”)
Applicant
Vycor Medical INC.
510(k) number
K202694
Product code
GZT  
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-14
Date received
2020-09-16
Regulation
882.4800
Classification name
Retractor, Self-retaining, For Neurosurgery
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Theo Novak
Address
951 Broken Sound Pkwy., Suite 320 Boca Raton FL US 33487 33487

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.2022-05-13
K202072MindsEye Expandable PortMinnetronix Neuro, Inc.2020-08-26
K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH2018-08-29
K172433NICO BrainPathNico Corporation2017-09-07
K161680MEDICON Spinal Spreading SystemsMedicon EG2017-03-24
K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding SystemsTedan Surgical Innovations, LLC2017-03-20
K161004Self-retaining RetractorFetzer Medical GmbH & Co. KG2016-09-09
K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation2015-06-12
K120691BRAIN PORTNico Corporation2012-06-05
K113273SPOTLIGHT ACCESS SYSTEMJohnson & Johnson2012-01-27
K112913SPOTLIGHT ACCESS SYSTEMJohnson & Johnson2011-12-16
K093054SCALP DURA RETRACTOR, MODEL KS00474KARL STORZ Endoscopy-America, Inc.2010-11-15
K090272SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)Cardinal Health, Inc.2009-03-18
K071771INSTRUMED RETRACTORSInstrumed International, Inc.2007-08-02
K071338FLEX ARM RETRACTOR SYSTEMKoros USA, Inc.2007-05-29

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases