FFX — System, Gastrointestinal Motility (Electrical) Class II
FDA product code FFX covers "System, Gastrointestinal Motility (Electrical)", a Class II medical device regulated under 21 CFR 876.1725. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |