FFX · System, Gastrointestinal Motility (Electrical)
Gastroenterology, Urology · 21 CFR 876.1725 · Class 2
Overview
| Product Code | FFX |
|---|---|
| Device Name | System, Gastrointestinal Motility (Electrical) |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 69)
Showing 20 most recent of 69 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | Dec 5, 2025 | SESE |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | May 6, 2024 | SESE |
| K231861 | EndoflipTM 300 System | Covidien, LLC | Jul 21, 2023 | SESE |
| K223705 | EndoflipTM 300 | Covidien, LLC | Apr 14, 2023 | SESE |
| K222000 | Transit-Pellets | Medifactia AB | Jan 18, 2023 | SESE |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | May 21, 2020 | SESE |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp | Dec 18, 2019 | SESE |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | Oct 3, 2019 | SESE |
| K181760 | Transit-Pellets | Medifactia AB | Aug 8, 2019 | SESE |
| K183072 | EndoFLIP System | Crospon, Ltd. | Feb 15, 2019 | SESE |
| K181750 | SITZMARKS | Konsyl Pharmaceuticals | Nov 15, 2018 | SESE |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | Apr 17, 2017 | SESE |
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | Mar 14, 2017 | SESE |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | Jun 20, 2016 | SESE |
| K160725 | EndoFLIP | Crospon, Ltd. | May 1, 2016 | SESE |
| K151086 | ManoScan System | Given Imaging , Ltd. | Apr 28, 2016 | SESE |
| K130906 | ENDOFLIP CATHETER | Crospon, Ltd. | Jul 17, 2013 | SESE |
| K122294 | PRESSURIZED INFUSION PUMP | Mui Scientific | Nov 1, 2012 | SESE |
| K120997 | BAROSTAT SOFTWARE OPTION | Crospon, Ltd. | Aug 27, 2012 | SESE |
| K121014 | SOLAR GI | Medical Measurement Systems B.V. | Aug 1, 2012 | SESE |
Top Applicants
- Crospon, Ltd. — 7 clearances
- Medtronic Functional Diagnostics A/S — 7 clearances
- Sandhill Scientific, Inc. — 6 clearances
- Medical Measurement Systems B.V. — 5 clearances
- Mui Scientific — 4 clearances
