System, Gastrointestinal Motility (Electrical)
FDA product code FFX · Class II (moderate risk) · 21 CFR 876.1725 · Gastroenterology, Urology
69510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Medtronic Functional Diagnostics A/S 7
- Crospon, Ltd. 7
- Sandhill Scientific, Inc. 6
- Medical Measurement Systems B.V. 5
- Mui Scientific 4
- Honeywell, Inc. 2
- G & J Electronics, Inc. 2
- Unisensor AG 2
- Dentsleeve Pty., Ltd. 2
- Sierra Scientific Instruments, Inc. 2
- Anx Robotica Corp 2
- Wilson-Cook Medical, Inc. 2
- Medifactia AB 2
- Covidien LLC 2
- Medical Measurements, Inc. 1
- Diagnostic Ultrasound Corp. 1
- Medics Instrument Corp. 1
- Medspira, LLC 1
- Narco Bio-Systems 1
- J.S. Biomedicals, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)FFX · Traditional | Medspira, LLC | 12/05/2025SE |
| K240007 | Solar Compact (G4-1)FFX · Traditional | Laborie Medical Technologies, Corp. | 05/06/2024SE |
| K231861 | EndoflipTM 300 SystemFFX · Special | Covidien, LLC | 07/21/2023SE |
| K223705 | EndoflipTM 300FFX · Traditional | Covidien, LLC | 04/14/2023SE |
| K222000 | Transit-PelletsFFX · Traditional | Medifactia AB | 01/18/2023SE |
| K201106 | IntraMarX 3D Radiopaque MarkerFFX · Special | Anx Robotica Corp | 05/21/2020SE |
| K191087 | IntraMarX Radiopaque MarkersFFX · Traditional | Anx Robotica Corp | 12/18/2019SE |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX · Traditional | Diversatek Healthcare | 10/03/2019SE |
| K181760 | Transit-PelletsFFX · Traditional | Medifactia AB | 08/08/2019SE |
| K183072 | EndoFLIP SystemFFX · Traditional | Crospon, Ltd. | 02/15/2019SE |
| K181750 | SitzmarksFFX · Traditional | Konsyl Pharmaceuticals | 11/15/2018SE |
| K170833 | EndoFLIP® System with FLIP Topography moduleFFX · Special | Crospon, Ltd. | 04/17/2017SE |
| K160287 | Rapid Barostat Bag (RBB) Pump and CatheterFFX · Traditional | Mui Scientific | 03/14/2017SE |
| K160170 | Lehman Manometry CatheterFFX · Special | Wilson-Cook Medical, Inc. | 06/20/2016SE |
| K160725 | EndoFLIPFFX · Traditional | Crospon, Ltd. | 05/01/2016SE |
| K151086 | ManoScan SystemFFX · Traditional | Given Imaging , Ltd. | 04/28/2016SE |
| K130906 | Endoflip CatheterFFX · Traditional | Crospon, Ltd. | 07/17/2013SE |
| K122294 | Pressurized Infusion PumpFFX · Traditional | Mui Scientific | 11/01/2012SE |
| K120997 | Barostat Software OptionFFX · Traditional | Crospon, Ltd. | 08/27/2012SE |
| K121014 | Solar GiFFX · Traditional | Medical Measurement Systems B.V. | 08/01/2012SE |
| K120524 | Sphincter of Oddi Manometric (Som) SystemFFX · Traditional | Mui Scientific | 06/21/2012SE |
| K102214 | Endo FlipFFX · Traditional | Crospon, Ltd. | 12/16/2010SE |
| K102801 | Phtip Disposable Isfet CatheterFFX · Traditional | E-Cath Co., Ltd. | 10/26/2010SE |
| K092850 | EndoflipFFX · Traditional | Crospon, Ltd. | 12/15/2009SE |
| K091070 | Manoscan Motility with Impedance Visualization SystemFFX · Traditional | Sierra Scientific Instruments, Inc. | 05/19/2009SE |
| K082056 | Anorectal Manometry Software Option ARM-1FFX · Traditional | Life-Tech, Inc. | 11/07/2008SE |
| K071094 | Modification to Solar GiFFX · Traditional | Medical Measurement Systems B.V. | 08/13/2007SE |
| K062222 | Unitip High Resolution CatheterFFX · Traditional | Unisensor AG | 03/15/2007SE |
| K060166 | OhmegaFFX · Traditional | Medical Measurement Systems B.V. | 04/21/2006SE |
| K052338 | Solar GiFFX · Special | Medical Measurement Systems B.V. | 12/15/2005SE |
| K031084 | Solar Gi SystemFFX · Traditional | Medical Measurement Systems B.V. | 03/19/2004SE |
| K031169 | Motility Visualization SystemFFX · Traditional | Sierra Scientific Instruments, Inc. | 12/12/2003SE |
| K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberFFX · Traditional | Medtronic Functional Diagnostics A/S | 11/08/2002SE |
| K012232 | Insight, Model S980000FFX · Traditional | Sandhill Scientific, Inc. | 06/07/2002SE |
| K013154 | Mark Ii/Mark III Manometric Perfusion PumpFFX · Special | Dentsleeve Pty., Ltd. | 10/19/2001SE |
| K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…FFX · Traditional | Medtronic Functional Diagnostics A/S | 08/10/2001SE |
| K003580 | Unitip Gastrointestinal Pressure Sensor CatheterFFX · Abbreviated | Unisensor AG | 07/31/2001SE |
| K002427 | Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026FFX · Abbreviated | Sandhill Scientific, Inc. | 06/22/2001SE |
| K004040 | Redtech Gipc 2000FFX · Traditional | Red-Tech, Inc. | 03/29/2001SE |
| K010130 | Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103FFX · Special | Medtronic Functional Diagnostics A/S | 02/07/2001SE |
| K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111FFX · Traditional | Medtronic Functional Diagnostics A/S | 05/05/2000SE |
| K992713 | Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models…FFX · Traditional | Medtronic Functional Diagnostics A/S | 11/10/1999SE |
| K991389 | Anorectal Manometry Suite, Model 9032S0201FFX · Traditional | Medtronic Functional Diagnostics A/S | 07/15/1999SE |
| K991288 | Distender Series II BarostatFFX · Traditional | G & J Electronics, Inc. | 06/08/1999SE |
| K973844 | Gastric and Rectal CathetersFFX · Traditional | G & J Electronics, Inc. | 06/04/1999SE |
| K990441 | Insight Sphincter of Oddi Manometry Module, Model S981300FFX · Traditional | Sandhill Scientific, Inc. | 05/12/1999SE |
| K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111FFX · Traditional | Medtronic Functional Diagnostics A/S | 02/04/1999SE |
| K984444 | Insight Gastrointestinal Motility System, Model S980000FFX · Special | Sandhill Scientific, Inc. | 01/11/1999SE |
| K980980 | Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50FFX · Traditional | Konigsberg Instruments, Inc. | 06/15/1998SE |
| K980946 | Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion PumpFFX · Traditional | Dentsleeve Pty., Ltd. | 06/08/1998SE |
| K972439 | Anorectal Manometry Analysis ModuleFFX · Traditional | Medtronic-Synectics | 09/23/1997SE |
| K963064 | Ano-Rectal Manometry Option, Model Number Uds-ArmFFX · Traditional | Laborie Medical Tech Corp. | 06/05/1997SE |
| K942247 | Small Bowel Analysis SoftwareFFX · Traditional | Sandhill Scientific, Inc. | 04/09/1996SE |
| K921682 | Zinetics AmcFFX · Traditional | Zinetics Medical, Inc. | 12/29/1994SE |
| K932306 | MicroinfusorFFX · Traditional | Sandhill Scientific, Inc. | 04/01/1994SE |
| K920664 | Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi VersionFFX · Traditional | Diagnostic Ultrasound Corp. | 12/23/1993SE |
| K921062 | Gaeltec MPR SeriesFFX · Traditional | Medical Measurements, Inc. | 07/30/1992SE |
| K905154 | GastroscanFFX · Traditional | Medics Instrument Corp. | 06/19/1991SE |
| K900058 | Wilson-Cook Biliary Motility CatheterFFX · Traditional | Wilson-Cook Medical, Inc. | 07/27/1990SE |
| K880581 | Ambul. PH & Motility Recorder for Measure of Para.FFX · Traditional | Synectics-Dantec | 08/11/1988SE |
| K881609 | SitzmarksFFX · Traditional | Lafayette Pharmacal, Inc. | 07/08/1988SE |
| K874690 | Gastroplasty Calibrating Tube & GastrostenometerFFX · Traditional | Mentor Corp. | 02/08/1988SE |
| K832869 | Motility Measurement Sys MMS-100FFX · Traditional | Narco Bio-Systems | 10/31/1983SE |
| K831347 | Microcapillary Infusion SystemFFX · Traditional | J.S. Biomedicals, Inc. | 06/02/1983SE |
| K830421 | SYN-02 PN AmplifierFFX · Traditional | Biosearch Medical Products, Inc. | 04/06/1983SE |
| K823701 | Motility CathetersFFX · Traditional | Mui Scientific | 02/15/1983SE |
| K812103 | Esophageal Motility ApparatusFFX · Traditional | Honeywell, Inc. | 08/13/1981SE |
| K780812 | Esophageal Motility System - Model 3330FFX · Traditional | Honeywell, Inc. | 06/13/1978SE |
| K760761 | Esophageal Motility TubeFFX · Traditional | Sherwood Medical Industries | 11/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2669-2026 Class II | Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p…Under extended clinical use conditions (e.g., long duration studies), moisture generated within the… | Laborie Medical Technologies Corp | 05/21/2026Open, Classified |
| Z-2950-2026 Class II | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307…Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the… | Covidien, LLC | 05/13/2026Open, Classified |
| Z-2324-2025 Class III | Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the… | Diversatek Healthcare | 06/04/2025Open, Classified |
| Z-2521-2023 Class III | ZVU Functional GI Software, REF: ZVU-3GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. | Diversatek Healthcare | 07/25/2023Open, Classified |
| Z-0135-2012 | AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label:…The recall was initiated after Given Imaging received a test report during a Canadian licensing process… | Sierra Scientific Instruments Inc | 10/12/2011Terminated |
| Z-1487-2012 | Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use…Software error may produce incorrect esophageal contraction readings. | Sandhill Scientific, Inc | 02/23/2009Terminated |