FDA Product Code GZT: Retractor, Self-retaining, For Neurosurgery
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Geister Medizin Technik GmbH and Minnetronix Neuro, Inc..
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
Cleared
May 13, 2022
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
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”)
Vycor Medical, Inc.
Neurology
120d
Cleared
Aug 26, 2020
MindsEye Expandable Port
Minnetronix Neuro, Inc.
Neurology
30d
Cleared
Aug 29, 2018
Geister retractor for neuro - and spine surgery
Geister Medizin Technik GmbH
General & Plastic Surgery
174d
Cleared
Nov 15, 2010
SCALP DURA RETRACTOR, MODEL KS00474
KARL STORZ Endoscopy-America, Inc.
Neurology
411d
Cleared
Oct 19, 1989
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
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.