FFX — System, Gastrointestinal Motility (Electrical) Class II
FDA Device Classification
Classification Details
- Product Code
- FFX
- Device Class
- Class II
- Regulation Number
- 876.1725
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252605 | medspira | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | December 5, 2025 |
| K240007 | laborie medical technologies | Solar Compact (G4-1) | May 6, 2024 |
| K231861 | covidien | EndoflipTM 300 System | July 21, 2023 |
| K223705 | covidien | EndoflipTM 300 | April 14, 2023 |
| K222000 | medifactia | Transit-Pellets | January 18, 2023 |
| K201106 | anx robotica | IntraMarX 3D Radiopaque Marker | May 21, 2020 |
| K191087 | anx robotica | IntraMarX Radiopaque Markers | December 18, 2019 |
| K190208 | diversatek healthcare | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | October 3, 2019 |
| K181760 | medifactia | Transit-Pellets | August 8, 2019 |
| K183072 | crospon | EndoFLIP System | February 15, 2019 |
| K181750 | konsyl pharmaceuticals | SITZMARKS | November 15, 2018 |
| K170833 | crospon | EndoFLIP® System with FLIP Topography module | April 17, 2017 |
| K160287 | mui scientific | Rapid Barostat Bag (RBB) Pump and Catheter | March 14, 2017 |
| K160170 | wilson-cook medical | Lehman Manometry Catheter | June 20, 2016 |
| K160725 | crospon | EndoFLIP | May 1, 2016 |
| K151086 | given imaging | ManoScan System | April 28, 2016 |
| K130906 | crospon | ENDOFLIP CATHETER | July 17, 2013 |
| K122294 | mui scientific | PRESSURIZED INFUSION PUMP | November 1, 2012 |
| K120997 | crospon | BAROSTAT SOFTWARE OPTION | August 27, 2012 |
| K121014 | medical measurement systems | SOLAR GI | August 1, 2012 |