Product Code: FFX FDA class 2 21 CFR 876.1725

System, Gastrointestinal Motility (Electrical)

Gastroenterology, Urology

The Electrical Gastrointestinal Motility System is a diagnostic device that uses electrical sensors and recording equipment to measure and characterize the motility and motor function of the gastrointestinal tract. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FFX, regulated under 21 CFR 876.1725, within the Gastroenterology, Urology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: FFX
Device Class: FDA class 2
Regulation Number: 876.1725
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 69 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252605	mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)	Dec 05, 2025	Substantially Equivalent	Medspira, LLC
K240007	Solar Compact (G4-1)	May 06, 2024	Substantially Equivalent	Laborie Medical Technologies, Corp.
K231861	EndoflipTM 300 System	Jul 21, 2023	Substantially Equivalent	Covidien, LLC
K223705	EndoflipTM 300	Apr 14, 2023	Substantially Equivalent	Covidien, LLC
K222000	Transit-Pellets	Jan 18, 2023	Substantially Equivalent	Medifactia AB
K201106	IntraMarX 3D Radiopaque Marker	May 21, 2020	Substantially Equivalent	Anx Robotica Corp
K191087	IntraMarX Radiopaque Markers	Dec 18, 2019	Substantially Equivalent	Anx Robotica Corp
K190208	Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe	Oct 03, 2019	Substantially Equivalent	Diversatek Healthcare
K181760	Transit-Pellets	Aug 08, 2019	Substantially Equivalent	Medifactia AB
K183072	EndoFLIP System	Feb 15, 2019	Substantially Equivalent	Crospon, Ltd.
K181750	SITZMARKS	Nov 15, 2018	Substantially Equivalent	Konsyl Pharmaceuticals
K170833	EndoFLIP® System with FLIP Topography module	Apr 17, 2017	Substantially Equivalent	Crospon, Ltd.
K160287	Rapid Barostat Bag (RBB) Pump and Catheter	Mar 14, 2017	Substantially Equivalent	Mui Scientific
K160170	Lehman Manometry Catheter	Jun 20, 2016	Substantially Equivalent	Wilson-Cook Medical, Inc.
K160725	EndoFLIP	May 01, 2016	Substantially Equivalent	Crospon, Ltd.
K151086	ManoScan System	Apr 28, 2016	Substantially Equivalent	Given Imaging , Ltd.
K130906	ENDOFLIP CATHETER	Jul 17, 2013	Substantially Equivalent	Crospon, Ltd.
K122294	PRESSURIZED INFUSION PUMP	Nov 01, 2012	Substantially Equivalent	Mui Scientific
K120997	BAROSTAT SOFTWARE OPTION	Aug 27, 2012	Substantially Equivalent	Crospon, Ltd.
K121014	SOLAR GI	Aug 01, 2012	Substantially Equivalent	Medical Measurement Systems B.V.
K120524	SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM	Jun 21, 2012	Substantially Equivalent	Mui Scientific
K102214	ENDO FLIP	Dec 16, 2010	Substantially Equivalent	Crospon, Ltd.
K102801	PHTIP DISPOSABLE ISFET CATHETER	Oct 26, 2010	Substantially Equivalent	E-Cath Co., Ltd.
K092850	ENDOFLIP	Dec 15, 2009	Substantially Equivalent	Crospon, Ltd.
K091070	MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM	May 19, 2009	Substantially Equivalent	Sierra Scientific Instruments, Inc.
K082056	ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1	Nov 07, 2008	Substantially Equivalent	Life-Tech, Inc.
K071094	MODIFICATION TO SOLAR GI	Aug 13, 2007	Substantially Equivalent	Medical Measurement Systems B.V.
K062222	UNITIP HIGH RESOLUTION CATHETER	Mar 15, 2007	Substantially Equivalent	Unisensor AG
K060166	OHMEGA	Apr 21, 2006	Substantially Equivalent	Medical Measurement Systems B.V.
K052338	SOLAR GI	Dec 15, 2005	Substantially Equivalent	Medical Measurement Systems B.V.
K031084	SOLAR GI SYSTEM	Mar 19, 2004	Substantially Equivalent	Medical Measurement Systems B.V.
K031169	MOTILITY VISUALIZATION SYSTEM	Dec 12, 2003	Substantially Equivalent	Sierra Scientific Instruments, Inc.
K011471	BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER	Nov 08, 2002	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K012232	INSIGHT, MODEL S980000	Jun 07, 2002	Substantially Equivalent	Sandhill Scientific, Inc.
K013154	MARK II/MARK III MANOMETRIC PERFUSION PUMP	Oct 19, 2001	Substantially Equivalent	Dentsleeve Pty., Ltd.
K011472	POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID	Aug 10, 2001	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K003580	UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER	Jul 31, 2001	Substantially Equivalent	Unisensor AG
K002427	SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026	Jun 22, 2001	Substantially Equivalent	Sandhill Scientific, Inc.
K004040	REDTECH GIPC 2000	Mar 29, 2001	Substantially Equivalent	Red-Tech, Inc.
K010130	POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103	Feb 07, 2001	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K000386	POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111	May 05, 2000	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K992713	POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101	Nov 10, 1999	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K991389	ANORECTAL MANOMETRY SUITE, MODEL 9032S0201	Jul 15, 1999	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K991288	DISTENDER SERIES II BAROSTAT	Jun 08, 1999	Substantially Equivalent	G & J Electronics, Inc.
K973844	GASTRIC AND RECTAL CATHETERS	Jun 04, 1999	Substantially Equivalent	G & J Electronics, Inc.
K990441	INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300	May 12, 1999	Substantially Equivalent	Sandhill Scientific, Inc.
K981733	DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111	Feb 04, 1999	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K984444	INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000	Jan 11, 1999	Substantially Equivalent	Sandhill Scientific, Inc.
K980980	MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50	Jun 15, 1998	Substantially Equivalent	Konigsberg Instruments, Inc.
K980946	MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP	Jun 08, 1998	Substantially Equivalent	Dentsleeve Pty., Ltd.
K972439	ANORECTAL MANOMETRY ANALYSIS MODULE	Sep 23, 1997	Substantially Equivalent	Medtronic-Synectics
K963064	ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM	Jun 05, 1997	Substantially Equivalent	Laborie Medical Tech Corp.
K942247	SMALL BOWEL ANALYSIS SOFTWARE	Apr 09, 1996	Substantially Equivalent	Sandhill Scientific, Inc.
K921682	ZINETICS AMC	Dec 29, 1994	Substantially Equivalent	Zinetics Medical, Inc.
K932306	MICROINFUSOR	Apr 01, 1994	Substantially Equivalent	Sandhill Scientific, Inc.
K920664	DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION	Dec 23, 1993	Substantially Equivalent	Diagnostic Ultrasound Corp.
K921062	GAELTEC MPR SERIES	Jul 30, 1992	Substantially Equivalent	Medical Measurements, Inc.
K905154	GASTROSCAN	Jun 19, 1991	Substantially Equivalent	Medics Instrument Corp.
K900058	WILSON-COOK BILIARY MOTILITY CATHETER	Jul 27, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K880581	AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.	Aug 11, 1988	Substantially Equivalent	Synectics-Dantec
K881609	SITZMARKS	Jul 08, 1988	Substantially Equivalent	Lafayette Pharmacal, Inc.
K874690	GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER	Feb 08, 1988	Substantially Equivalent	Mentor Corp.
K832869	MOTILITY MEASUREMENT SYS MMS-100	Oct 31, 1983	Substantially Equivalent	Narco Bio-Systems
K831347	MICROCAPILLARY INFUSION SYSTEM	Jun 02, 1983	Substantially Equivalent	J.S. Biomedicals, Inc.
K830421	SYN-02 PN AMPLIFIER	Apr 06, 1983	Substantially Equivalent	Biosearch Medical Products, Inc.
K823701	MOTILITY CATHETERS	Feb 15, 1983	Substantially Equivalent	Mui Scientific
K812103	ESOPHAGEAL MOTILITY APPARATUS	Aug 13, 1981	Substantially Equivalent	Honeywell, Inc.
K780812	ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330	Jun 13, 1978	Substantially Equivalent	Honeywell, Inc.
K760761	ESOPHAGEAL MOTILITY TUBE	Nov 30, 1976	Substantially Equivalent	Sherwood Medical Industries