System, Gastrointestinal Motility (Electrical)
FDA product code FFX · 69 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.1725
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-30 – 2025-12-05
FFX
2025-12-05
FFX
2024-05-06
Solar Compact (G4-1)
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FFX
2023-07-21
EndoflipTM 300 System
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FFX
2023-04-14
EndoflipTM 300
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FFX
2023-01-18
Transit-Pellets
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FFX
2020-05-21
IntraMarX 3D Radiopaque Marker
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FFX
2019-12-18
IntraMarX Radiopaque Markers
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FFX
2019-10-03
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
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FFX
2019-08-08
Transit-Pellets
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FFX
2019-02-15
EndoFLIP System
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FFX
2018-11-15
SITZMARKS
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FFX
2017-04-17
EndoFLIP® System with FLIP Topography module
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FFX
2017-03-14
Rapid Barostat Bag (RBB) Pump and Catheter
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FFX
2016-06-20
Lehman Manometry Catheter
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FFX
2016-05-01
EndoFLIP
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FFX
2016-04-28
ManoScan System
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FFX
2013-07-17
ENDOFLIP CATHETER
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FFX
2012-11-01
PRESSURIZED INFUSION PUMP
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FFX
2012-08-27
BAROSTAT SOFTWARE OPTION
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FFX
2012-08-01
SOLAR GI
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FFX
2012-06-21
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
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FFX
2010-12-16
ENDO FLIP
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FFX
2010-10-26
PHTIP DISPOSABLE ISFET CATHETER
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FFX
2009-12-15
ENDOFLIP
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FFX
2009-05-19
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
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FFX
2008-11-07
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
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FFX
2007-08-13
MODIFICATION TO SOLAR GI
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FFX
2007-03-15
UNITIP HIGH RESOLUTION CATHETER
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FFX
2006-04-21
OHMEGA
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FFX
2005-12-15
SOLAR GI
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FFX
2004-03-19
SOLAR GI SYSTEM
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FFX
2003-12-12
MOTILITY VISUALIZATION SYSTEM
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FFX
2002-11-08
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
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FFX
2002-06-07
INSIGHT, MODEL S980000
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FFX
2001-10-19
MARK II/MARK III MANOMETRIC PERFUSION PUMP
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FFX
2001-08-10
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
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FFX
2001-07-31
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
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FFX
2001-06-22
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
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FFX
2001-03-29
REDTECH GIPC 2000
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FFX
2001-02-07
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
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FFX
2000-05-05
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
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FFX
1999-11-10
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
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FFX
1999-07-15
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
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FFX
1999-06-08
DISTENDER SERIES II BAROSTAT
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FFX
1999-06-04
GASTRIC AND RECTAL CATHETERS
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FFX
1999-05-12
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
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FFX
1999-02-04
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
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FFX
1999-01-11
INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
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FFX
1998-06-15
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
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FFX
1998-06-08
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
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FFX
1997-09-23
ANORECTAL MANOMETRY ANALYSIS MODULE
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FFX
1997-06-05
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
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FFX
1996-04-09
SMALL BOWEL ANALYSIS SOFTWARE
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FFX
1994-12-29
ZINETICS AMC
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FFX
1994-04-01
MICROINFUSOR
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FFX
1993-12-23
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
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FFX
1992-07-30
GAELTEC MPR SERIES
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FFX
1991-06-19
GASTROSCAN
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FFX
1990-07-27
WILSON-COOK BILIARY MOTILITY CATHETER
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FFX
1988-08-11
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
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FFX
1988-07-08
SITZMARKS
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FFX
1988-02-08
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
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FFX
1983-10-31
MOTILITY MEASUREMENT SYS MMS-100
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FFX
1983-06-02
MICROCAPILLARY INFUSION SYSTEM
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FFX
1983-04-06
SYN-02 PN AMPLIFIER
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FFX
1983-02-15
MOTILITY CATHETERS
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FFX
1981-08-13
ESOPHAGEAL MOTILITY APPARATUS
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FFX
1978-06-13
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
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FFX
1976-11-30
ESOPHAGEAL MOTILITY TUBE
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