FDA Product Code GWG: Endoscope, Neurological
Direct visualization of the brain and spinal canal enables minimally invasive neurosurgical procedures. FDA product code GWG covers neurological endoscopes and their accessories.
These rigid or flexible endoscopes provide direct optical access to the ventricular system, spinal canal, and intracranial spaces for the treatment of hydrocephalus, intraventricular tumors, and syringomyelia through minimally invasive approaches.
GWG devices are Class II medical devices, regulated under 21 CFR 882.1480 and reviewed by the FDA Neurology panel.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Aesculap, Inc. and Penumbra, Inc..
93
Total
93
Cleared
157d
Avg days
1992
Since
93 devices
Cleared
Feb 03, 1995
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
Johnson & Johnson Professionals, Inc.
Neurology
81d
Cleared
Jul 11, 1994
AESCULAP NEUROENDOSCOPE
Aesculap, Inc.
Neurology
118d
Cleared
May 03, 1994
PS MEDICAL CATHETER PLACEMENT KIT
Pudenz-Schulte Medical Research Corp.
Neurology
116d
Cleared
Apr 12, 1994
CODMAN QUICK SHUNT KIT, CAT. #82-6570
Codman & Shurtleff, Inc.
Neurology
229d
Cleared
Nov 22, 1993
CODMAN LASER NEUROENDOSCOPE
Codman & Shurtleff, Inc.
Neurology
417d
Cleared
Dec 21, 1992
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
Codman & Shurtleff, Inc.
Neurology
153d