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 Medical Systems, Inc. and Browne Corp..

85
Total
85
Cleared
116d
Avg days
1977
Since
85 devices
73–85 of 85
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 Dec 06, 1979
BROWNE MODEL UD-4
K792090
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UD-4D
K792091
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UD-4E
K792092
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL GD-5
K792093
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UA-6
K792094
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Jun 01, 1979
BROWNE MODEL UD-4DE
K790478
Browne Corp.
Gastroenterology & Urology · 84d
Cleared Jun 01, 1979
BROWNE MODEL CF-1 AND CF-1G
K790754
Browne Corp.
Gastroenterology & Urology · 45d
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