FFX · Class II · 21 CFR 876.1725

FDA Product Code FFX: System, Gastrointestinal Motility (electrical)

Leading manufacturers include Medtronic Functional Diagnostics A/S, Crospon, Ltd. and Sandhill Scientific, Inc..

70
Total
70
Cleared
177d
Avg days
1976
Since
70 devices
25–48 of 70
Cleared Dec 15, 2009
ENDOFLIP
K092850
Crospon, Ltd.
Gastroenterology & Urology · 90d
Cleared May 19, 2009
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
K091070
Sierra Scientific Instruments, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 07, 2008
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
K082056
Life-Tech, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 13, 2007
MODIFICATION TO SOLAR GI
K071094
Medical Measurement Systems B.V.
Gastroenterology & Urology · 117d
Cleared Mar 15, 2007
UNITIP HIGH RESOLUTION CATHETER
K062222
Unisensor AG
Gastroenterology & Urology · 225d
Cleared Apr 21, 2006
OHMEGA
K060166
Medical Measurement Systems B.V.
Gastroenterology & Urology · 88d
Cleared Dec 15, 2005
SOLAR GI
K052338
Medical Measurement Systems B.V.
Gastroenterology & Urology · 111d
Cleared Mar 19, 2004
SOLAR GI SYSTEM
K031084
Medical Measurement Systems B.V.
Gastroenterology & Urology · 350d
Cleared Dec 12, 2003
MOTILITY VISUALIZATION SYSTEM
K031169
Sierra Scientific Instruments, Inc.
Gastroenterology & Urology · 242d
Cleared Nov 08, 2002
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
K011471
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 543d
Cleared Jun 07, 2002
INSIGHT, MODEL S980000
K012232
Sandhill Scientific, Inc.
Gastroenterology & Urology · 326d
Cleared Oct 19, 2001
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 29d
Cleared Aug 10, 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
K011472
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared Jul 31, 2001
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K003580
Unisensor AG
Gastroenterology & Urology · 253d
Cleared Jun 22, 2001
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427
Sandhill Scientific, Inc.
Gastroenterology & Urology · 318d
Cleared Mar 29, 2001
REDTECH GIPC 2000
K004040
Red-Tech, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 07, 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
K010130
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 22d
Cleared May 05, 2000
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
K000386
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared Nov 10, 1999
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
K992713
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 90d
Cleared Jul 15, 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 85d
Cleared Jun 08, 1999
DISTENDER SERIES II BAROSTAT
K991288
G & J Electronics, Inc.
Gastroenterology & Urology · 55d
Cleared Jun 04, 1999
GASTRIC AND RECTAL CATHETERS
K973844
G & J Electronics, Inc.
Gastroenterology & Urology · 604d
Cleared May 12, 1999
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
K990441
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 04, 1999
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
K981733
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 262d