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GZT — Retractor, Self-Retaining, For Neurosurgery Class II

FDA Device Classification

Classification Details

Product Code
GZT
Device Class
Class II
Regulation Number
882.4800
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K210615thompson surgical instrumentsThompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull ClamMay 13, 2022
K202694vycor medicalVycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment ClipJanuary 14, 2021
K202072minnetronix neuroMindsEye Expandable PortAugust 26, 2020
K180610geister medizin technikGeister retractor for neuro - and spine surgeryAugust 29, 2018
K172433nico corporationNICO BrainPathSeptember 7, 2017
K161680medicon egMEDICON Spinal Spreading SystemsMarch 24, 2017
K161318tedan surgical innovationsPhantom Fukushima Neurological Holding Systems, Phantom Mastability NeurologicalMarch 20, 2017
K161004fetzer medical gmbh and co. kgSelf-retaining RetractorSeptember 9, 2016
K150378nico corporationNICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookJune 12, 2015
K120691nico corporationBRAIN PORTJune 5, 2012
K113273johnson and johnsonSPOTLIGHT ACCESS SYSTEMJanuary 27, 2012
K112913johnson and johnsonSPOTLIGHT ACCESS SYSTEMDecember 16, 2011
K093054karl storz endoscopy-americaSCALP DURA RETRACTOR, MODEL KS00474November 15, 2010
K090272cardinal healthSPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)March 18, 2009
K071771instrumed internationalINSTRUMED RETRACTORSAugust 2, 2007
K071338koros usaFLEX ARM RETRACTOR SYSTEMMay 29, 2007
K062814depuy spinePIPELINE II ACCESS SYSTEMDecember 15, 2006
K060973vycor medicalVYCOR SURGICAL ACCESS SYSTEMSJuly 26, 2006
K060097kls-martin l.pGROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00February 27, 2006
K050706spinal conceptsHARMONY PORT SYSTEM, MODEL 1907 SERIESApril 15, 2005