Product code FFX
- Device name
- System, Gastrointestinal Motility (Electrical)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1725
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | 2025-12-05 |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| K231861 | EndoflipTM 300 System | Covidien, LLC | 2023-07-21 |
| K223705 | EndoflipTM 300 | Covidien, LLC | 2023-04-14 |
| K222000 | Transit-Pellets | Medifactia AB | 2023-01-18 |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | 2020-05-21 |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp | 2019-12-18 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | 2019-10-03 |
| K181760 | Transit-Pellets | Medifactia AB | 2019-08-08 |
| K183072 | EndoFLIP System | Crospon, Ltd. | 2019-02-15 |
| K181750 | SITZMARKS | Konsyl Pharmaceuticals | 2018-11-15 |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | 2017-04-17 |
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017-03-14 |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016-06-20 |
| K160725 | EndoFLIP | Crospon, Ltd. | 2016-05-01 |
| K151086 | ManoScan System | Given Imaging , Ltd. | 2016-04-28 |
| K130906 | ENDOFLIP CATHETER | Crospon, Ltd. | 2013-07-17 |
| K122294 | PRESSURIZED INFUSION PUMP | Mui Scientific | 2012-11-01 |
| K120997 | BAROSTAT SOFTWARE OPTION | Crospon, Ltd. | 2012-08-27 |
| K121014 | SOLAR GI | Medical Measurement Systems B.V. | 2012-08-01 |
| K120524 | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM | Mui Scientific | 2012-06-21 |
| K102214 | ENDO FLIP | Crospon, Ltd. | 2010-12-16 |
| K102801 | PHTIP DISPOSABLE ISFET CATHETER | E-Cath Co., Ltd. | 2010-10-26 |
| K092850 | ENDOFLIP | Crospon, Ltd. | 2009-12-15 |
| K091070 | MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM | Sierra Scientific Instruments, Inc. | 2009-05-19 |
| K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 | Life-Tech, Inc. | 2008-11-07 |
| K071094 | MODIFICATION TO SOLAR GI | Medical Measurement Systems B.V. | 2007-08-13 |
| K062222 | UNITIP HIGH RESOLUTION CATHETER | Unisensor AG | 2007-03-15 |
| K060166 | OHMEGA | Medical Measurement Systems B.V. | 2006-04-21 |
| K052338 | SOLAR GI | Medical Measurement Systems B.V. | 2005-12-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08717775955658 | CIM M4E | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955818 | PIM-Silver | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955801 | PIM-Gold | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955795 | GI Trolly Gold | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955788 | GI Trolly Silver | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955771 | S Trolly Gold | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955764 | S Trolly Silver | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955757 | MPI | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955733 | MPP Plus | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955726 | S-Puller GI | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955719 | S-Puller | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955696 | RC-1600 | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955689 | RC-1500 | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955672 | S-Puller-BT | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955665 | CIM H4E | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955641 | CIM E | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955627 | Flowsensor3 | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954798 | MPP-FR0.15T XL | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775953364 | MPP-FR0.6T | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775953357 | MPP-FR0.15T | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775953098 | Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775953050 | Impedance/pH, 6 imp channels, 1 pH antimony, Pediatric, 6.4 Fr | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775951964 | MPP-A | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775951087 | MPP-T | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775951070 | MPP-F | Medical Measurement Systems B.V. | 2016-09-23 |
| 07640172972434 | pHTip Disposable Catheter | Unisensor AG | 2016-09-19 |
| 07640172972519 | pHTip Disposable Catheter | Unisensor AG | 2016-09-19 |
| 07640172972496 | pHTip Disposable Catheter | Unisensor AG | 2016-09-19 |
| 07640172972472 | pHTip Disposable Catheter | Unisensor AG | 2016-09-19 |
| 07640172972458 | pHTip Disposable Catheter | Unisensor AG | 2016-09-19 |