GZT · Class II · 21 CFR 882.4800

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

Leading manufacturers include Nico Corporation, Ohio Medical Instrument Co., Inc. and T. Korossurgical Instruments Corp..

43
Total
43
Cleared
106d
Avg days
1980
Since
Stable submission activity - 0 submissions in the last 2 years

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

43 devices
1–24 of 43
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 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
Cleared Mar 22, 1994
CERVICAL SELF-RETAINING RETRACTOR
K935529
T. Korossurgical Instruments Corp.
Neurology · 126d
Cleared Jul 31, 1991
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233
Codman & Shurtleff, Inc.
Neurology · 9d
Cleared Oct 19, 1989
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K895395
Baxter Healthcare Corp
Neurology · 48d

About Product Code GZT - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code GZT since 1980, with 43 receiving FDA clearance (average review time: 106 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.