FAP · Class II · 21 CFR 876.1620

FDA Product Code FAP: Cystometric Gas (carbon-dioxide) On Hydraulic Device

Leading manufacturers include Life-Tech Intl., Inc., Browne Corp. and Browne Medical Systems, Inc..

85
Total
85
Cleared
116d
Avg days
1977
Since
85 devices
49–72 of 85
Cleared Oct 24, 1986
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
K863168
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d
Cleared Sep 09, 1986
MODEL AS-72 ADMINISTRATION SET
K863169
Life-Tech Intl., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 04, 1986
MODEL RCV REFLUX CHECK VALVE
K862327
Life-Tech Intl., Inc.
Gastroenterology & Urology · 77d
Cleared Mar 18, 1986
F.M. WEIST,KG (URODYNAMIC SYSTEMS)
K860571
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 32d
Cleared Jan 10, 1986
LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
K853059
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 175d
Cleared Jan 10, 1986
UMS-100
K853683
Narco Bio-Systems
Gastroenterology & Urology · 128d
Cleared Dec 02, 1985
1351 UROFLOW AUTO START
K853936
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Oct 17, 1985
LABORIE URODYNAMICS PROCESSOR
K852856
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 104d
Cleared Aug 07, 1985
UROBEI STRESS INCONTINENCE MONITOR
K851483
Browne Medical, Inc.
Gastroenterology & Urology · 114d
Cleared May 17, 1985
WSP CODE 4310 STRESSCATH
K850694
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
WSP CODE 4300 DIOMASTER DIAGNOSTIC
K850696
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 16, 1985
WSP CODE 4301 DIOMASTER THERAPEUTIC
K850695
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 84d
Cleared May 10, 1985
WSP CODE 4315 PADTEST
K850693
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 78d
Cleared Apr 25, 1985
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
K850601
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Apr 25, 1985
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
K850602
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Jan 02, 1985
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
K844503
Epcom Medical Systems, Inc.
Gastroenterology & Urology · 43d
Cleared Aug 08, 1984
EMG MODULE, EMG1, W/OPTIONAL SPEAKER
K842124
Endotek Corp.
Gastroenterology & Urology · 71d
Cleared Feb 21, 1984
PROFILE URODYNAMIC MONITORING SYS
K834503
Browne Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Nov 28, 1983
LUMEN-4 URODYNAMIC CATHETER
K833628
Surgitek
Gastroenterology & Urology · 45d
Cleared Jan 07, 1983
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561
Nihon Kohden America, Inc.
Gastroenterology & Urology · 36d
Cleared Dec 13, 1982
UROCOMP REMOTE CONTROL 1804
K822916
Life-Tech Intl., Inc.
Gastroenterology & Urology · 73d
Cleared Nov 30, 1982
1512M/F WIRE ELECTRODE NEEDLE SET
K823432
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d
Cleared Jul 13, 1982
UROCOMP MODEL 1404
K821939
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d
Cleared Mar 23, 1982
DISA WATER CYSTOMETER
K820144
Disa Electronics
Gastroenterology & Urology · 63d