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., Dantec Medical, Inc. and Life-Tech Instruments, Inc..

85
Total
85
Cleared
116d
Avg days
1977
Since
85 devices
25–48 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 Dec 02, 1985
1351 UROFLOW AUTO START
K853936
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
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 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 Aug 13, 1981
LIFE-TECH #'S 1106/1156 UROLABS
K812178
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 10d
Cleared Jun 17, 1980
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
K800822
Kli
Gastroenterology & Urology · 64d
Cleared May 14, 1979
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
K790519
American Medical Systems, Inc.
Gastroenterology & Urology · 59d
Cleared Oct 18, 1977
UROFLOW-CYSTOMETER SYSTEM
K771850
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 19d
Cleared May 23, 1977
CATHETER, URETHRAL PRESSURE, UPE-10 & 12
K770579
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 56d