FFX · Class II · 21 CFR 876.1725

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

Leading manufacturers include Sandhill Scientific, Inc., Crospon, Ltd. and Mui Scientific.

69
Total
69
Cleared
179d
Avg days
1976
Since
69 devices
25–48 of 69
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
Cleared Jan 11, 1999
INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
K984444
Sandhill Scientific, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 15, 1998
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
K980980
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 08, 1998
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
K980946
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 87d
Cleared Sep 23, 1997
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439
Medtronic-Synectics
Gastroenterology & Urology · 85d
Cleared Jun 05, 1997
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
K963064
Laborie Medical Tech Corp.
Gastroenterology & Urology · 302d
Cleared Apr 09, 1996
SMALL BOWEL ANALYSIS SOFTWARE
K942247
Sandhill Scientific, Inc.
Gastroenterology & Urology · 701d
Cleared Apr 01, 1994
MICROINFUSOR
K932306
Sandhill Scientific, Inc.
Gastroenterology & Urology · 325d
Cleared Dec 23, 1993
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
K920664
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 679d
Cleared Jul 27, 1990
WILSON-COOK BILIARY MOTILITY CATHETER
K900058
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 205d
Cleared Aug 11, 1988
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581
Synectics-Dantec
Gastroenterology & Urology · 183d
Cleared Feb 08, 1988
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690
Mentor Corp.
Gastroenterology & Urology · 84d
Cleared Apr 06, 1983
SYN-02 PN AMPLIFIER
K830421
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY APPARATUS
K812103
Honeywell, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 13, 1978
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812
Honeywell, Inc.
Gastroenterology & Urology · 27d
Cleared Nov 30, 1976
ESOPHAGEAL MOTILITY TUBE
K760761
Sherwood Medical Industries
Gastroenterology & Urology · 57d