GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Innerspace, Inc. and Raumedic AG.

105
Total
105
Cleared
149d
Avg days
1978
Since
105 devices
73–96 of 105
Cleared Apr 15, 1993
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221
Camino Laboratories, Inc.
Neurology · 90d
Cleared Mar 25, 1992
MODEL 704
K912139
Ivy Biomedical Systems, Inc.
Neurology · 316d
Cleared Jan 17, 1992
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K914735
Camino Laboratories, Inc.
Neurology · 88d
Cleared Jul 03, 1990
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823
Abbott Laboratories
Neurology · 592d
Cleared Feb 23, 1990
MODEL BT-1 FOT BOLT INSTALLATION KIT
K896834
Pearl Instruments Corp.
Neurology · 80d
Cleared Nov 22, 1989
MINI-MONITOR J7000 ICP
K893395
Ladd Research Industries, Inc.
Neurology · 205d
Cleared Apr 26, 1989
MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
K890468
Pearl Instruments Corp.
Neurology · 85d
Cleared Oct 27, 1988
MODIFIED MODEL 2001 FIBER OPTICS CATHETER
K883881
Metatech Corp.
Neurology · 90d
Cleared Sep 22, 1988
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
K883518
Metatech Corp.
Neurology · 37d
Cleared Sep 08, 1988
METATECH ROBINSON BOLT ACCESSORY
K882552
Metatech Corp.
Neurology · 79d
Cleared Aug 29, 1988
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115
Pmt Corp.
Neurology · 35d
Cleared Jul 18, 1988
EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
K882286
Metatech Corp.
Neurology · 47d
Cleared May 04, 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183
Camino Laboratories, Inc.
Neurology · 44d
Cleared Mar 28, 1988
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
K880154
Metatech Corp.
Neurology · 75d
Cleared Feb 26, 1987
LADD/STERITEK ICP MONITOR, CAT. NO. P3000
K862820
Ladd Research Industries, Inc.
Neurology · 216d
Cleared Oct 14, 1986
MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
K863479
Medical Measurements, Inc.
Neurology · 35d
Cleared Oct 06, 1986
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770
Codman & Shurtleff, Inc.
Neurology · 392d
Cleared Jun 09, 1986
LADD MEDICAL S-2000
K862012
Ladd Research Industries, Inc.
Neurology · 12d
Cleared Feb 20, 1986
INTRACRANIAL PRESSURE MONITORING KIT 070
K853864
Camino Laboratories, Inc.
Neurology · 156d
Cleared Dec 27, 1985
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657
Cordis Corp.
Neurology · 37d
Cleared Aug 16, 1985
ICP MONITOR MODEL 1000
K844566
Advanced Ultrasonic Testing & Research Corp.
Neurology · 266d
Cleared Apr 04, 1984
PHILLY INFANT BOLT
K840999
Philadelphia Medical Specialties
Neurology · 26d
Cleared Feb 28, 1984
DISPOSABLE ICP KIT DIFF. SIZES
K840003
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Nov 16, 1982
INTRACRANIAL PRESSURE MONITORING DEVICE
K822864
Medex, Inc.
Neurology · 50d