GZT · Class II · 21 CFR 882.4800

FDA Product Code GZT: Retractor, Self-retaining, For Neurosurgery

Leading manufacturers include Nico Corporation, T. Korossurgical Instruments Corp. and Johnson & Johnson.

44
Total
44
Cleared
112d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 364d recently vs 106d historically

FDA 510(k) Cleared Retractor, Self-retaining, For Neurosurgery Devices (Product Code GZT)

44 devices
1–24 of 44
Cleared Sep 17, 2026
Durashield Device Kit
K252995
SurGenTec, LLC
Neurology · 364d
Cleared May 13, 2022
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
K210615
Thompson Surgical Instruments, Inc.
Neurology · 438d
Cleared Jan 14, 2021
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
K202694
Vycor Medical, Inc.
Neurology · 120d
Cleared Aug 26, 2020
MindsEye Expandable Port
K202072
Minnetronix Neuro, Inc.
Neurology · 30d
Cleared Aug 29, 2018
Geister retractor for neuro - and spine surgery
K180610
Geister Medizin Technik GmbH
General & Plastic Surgery · 174d
Cleared Sep 07, 2017
NICO BrainPath
K172433
Nico Corporation
Neurology · 27d
Cleared Mar 24, 2017
MEDICON Spinal Spreading Systems
K161680
Medicon EG
Neurology · 280d
Cleared Mar 20, 2017
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
K161318
Tedan Surgical Innovations, LLC
Neurology · 313d
Cleared Sep 09, 2016
Self-retaining Retractor
K161004
Fetzer Medical GmbH & Co. KG
Neurology · 151d
Cleared Jun 12, 2015
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378
Nico Corporation
Neurology · 119d
Cleared Jun 05, 2012
BRAIN PORT
K120691
Nico Corporation
Neurology · 90d
Cleared Jan 27, 2012
SPOTLIGHT ACCESS SYSTEM
K113273
Johnson & Johnson
Neurology · 81d
Cleared Dec 16, 2011
SPOTLIGHT ACCESS SYSTEM
K112913
Johnson & Johnson
Neurology · 74d
Cleared Nov 15, 2010
SCALP DURA RETRACTOR, MODEL KS00474
K093054
KARL STORZ Endoscopy-America, Inc.
Neurology · 411d
Cleared Mar 18, 2009
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K090272
Cardinal Health, Inc.
Neurology · 42d
Cleared Aug 02, 2007
INSTRUMED RETRACTORS
K071771
Instrumed International, Inc.
Neurology · 34d
Cleared May 29, 2007
FLEX ARM RETRACTOR SYSTEM
K071338
Koros USA, Inc.
Neurology · 15d
Cleared Dec 15, 2006
PIPELINE II ACCESS SYSTEM
K062814
Depuy Spine, Inc.
Neurology · 86d
Cleared Jul 26, 2006
VYCOR SURGICAL ACCESS SYSTEMS
K060973
Vycor Medical, LLC
Neurology · 107d
Cleared Feb 27, 2006
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K060097
KLS-Martin L.P.
Neurology · 45d
Cleared Apr 15, 2005
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706
Spinal Concepts, Inc.
Neurology · 28d
Cleared Oct 21, 1999
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
K992898
Bright Medical Instruments
Neurology · 55d
Cleared Jan 23, 1997
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
K964402
V. Mueller Neuro/Spine
Neurology · 80d
Cleared May 17, 1996
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
K960807
Ohio Medical Instrument Co., Inc.
Neurology · 79d

About Product Code GZT - Regulatory Context

510(k) Submission Activity

44 total 510(k) submissions under product code GZT since 1980, with 44 receiving FDA clearance (average review time: 112 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GZT Product Code

Recent submissions under GZT have taken an average of 364 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.

GZT devices are reviewed by the Neurology panel. Browse all Neurology devices →