Panels › Gastroenterology, Urology › Product code FFX · Class 2
System, Gastrointestinal Motility (Electrical)
Regulation 876.1725
2510(k)s in 12 months (70 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in FFX
| Company | 510(k)s | Recalls |
|---|---|---|
| Crospon, Ltd. | 7 | 0 |
| Medtronic Functional Diagnostics A/S | 7 | 0 |
| Sandhill Scientific, Inc. | 6 | 1 |
| Medical Measurement Systems B.V. | 5 | 0 |
| Mui Scientific | 5 | 0 |
| Covidien, LLC | 2 | 1 |
| Diversatek Healthcare | 1 | 2 |
| Sierra Scientific Instruments, Inc. | 2 | 1 |
| Anx Robotica Corp | 2 | 0 |
| Dentsleeve Pty., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System Mui Scientific, Inc., CA | FFX |
| Dec 5, 2025 | K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) Medspira, LLC | FFX |
| May 6, 2024 | K240007 | Solar Compact (G4-1) Laborie Medical Technologies, Corp. | FFX |
| Jul 21, 2023 | K231861 | EndoflipTM 300 System Covidien, LLC | FFX |
| Apr 14, 2023 | K223705 | EndoflipTM 300 Covidien, LLC | FFX |
| Jan 18, 2023 | K222000 | Transit-Pellets Medifactia AB, SE | FFX |
| May 21, 2020 | K201106 | IntraMarX 3D Radiopaque Marker Anx Robotica Corp | FFX |
| Dec 18, 2019 | K191087 | IntraMarX Radiopaque Markers Anx Robotica Corp | FFX |
| Oct 3, 2019 | K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Diversatek Healthcare | FFX |
| Aug 8, 2019 | K181760 | Transit-Pellets Medifactia AB, SE | FFX |
| Feb 15, 2019 | K183072 | EndoFLIP System Crospon, Ltd., IE | FFX |
| Nov 15, 2018 | K181750 | SITZMARKS Konsyl Pharmaceuticals | FFX |
| Apr 17, 2017 | K170833 | EndoFLIP® System with FLIP Topography module Crospon, Ltd., IE | FFX |
| Mar 14, 2017 | K160287 | Rapid Barostat Bag (RBB) Pump and Catheter Mui Scientific, CA | FFX |
| Jun 20, 2016 | K160170 | Lehman Manometry Catheter Wilson-Cook Medical, Inc. | FFX |
| May 1, 2016 | K160725 | EndoFLIP Crospon, Ltd., IE | FFX |
| Apr 28, 2016 | K151086 | ManoScan System Given Imaging , Ltd., IL | FFX |
| Jul 17, 2013 | K130906 | ENDOFLIP CATHETER Crospon, Ltd. | FFX |
| Nov 1, 2012 | K122294 | PRESSURIZED INFUSION PUMP Mui Scientific, CA | FFX |
| Aug 27, 2012 | K120997 | BAROSTAT SOFTWARE OPTION Crospon, Ltd. | FFX |
| Aug 1, 2012 | K121014 | SOLAR GI Medical Measurement Systems B.V., NL | FFX |
| Jun 21, 2012 | K120524 | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM Mui Scientific, CA | FFX |
| Dec 16, 2010 | K102214 | ENDO FLIP Crospon, Ltd. | FFX |
| Oct 26, 2010 | K102801 | PHTIP DISPOSABLE ISFET CATHETER E-Cath Co., Ltd. | FFX |
| Dec 15, 2009 | K092850 | ENDOFLIP Crospon, Ltd. | FFX |
| May 19, 2009 | K091070 | MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM Sierra Scientific Instruments, Inc. | FFX |
| Nov 7, 2008 | K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 Life-Tech, Inc. | FFX |
| Aug 13, 2007 | K071094 | MODIFICATION TO SOLAR GI Medical Measurement Systems B.V., NL | FFX |
| Mar 15, 2007 | K062222 | UNITIP HIGH RESOLUTION CATHETER Unisensor AG | FFX |
| Apr 21, 2006 | K060166 | OHMEGA Medical Measurement Systems B.V., NL | FFX |
| Dec 15, 2005 | K052338 | SOLAR GI Medical Measurement Systems B.V., NL | FFX |
| Mar 19, 2004 | K031084 | SOLAR GI SYSTEM Medical Measurement Systems B.V., NL | FFX |
| Dec 12, 2003 | K031169 | MOTILITY VISUALIZATION SYSTEM Sierra Scientific Instruments, Inc. | FFX |
| Nov 8, 2002 | K011471 | BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER Medtronic Functional Diagnostics A/S, DK | FFX |
| Jun 7, 2002 | K012232 | INSIGHT, MODEL S980000 Sandhill Scientific, Inc. | FFX |
| Oct 19, 2001 | K013154 | MARK II/MARK III MANOMETRIC PERFUSION PUMP Dentsleeve Pty., Ltd. | FFX |
| Aug 10, 2001 | K011472 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID Medtronic Functional Diagnostics A/S, DK | FFX |
| Jul 31, 2001 | K003580 | UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER Unisensor AG | FFX |
| Jun 22, 2001 | K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 Sandhill Scientific, Inc. | FFX |
| Mar 29, 2001 | K004040 | REDTECH GIPC 2000 Red-Tech, Inc. | FFX |
| Feb 7, 2001 | K010130 | POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 Medtronic Functional Diagnostics A/S, DK | FFX |
| May 5, 2000 | K000386 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 Medtronic Functional Diagnostics A/S, DK | FFX |
| Nov 10, 1999 | K992713 | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 Medtronic Functional Diagnostics A/S, DK | FFX |
| Jul 15, 1999 | K991389 | ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 Medtronic Functional Diagnostics A/S, DK | FFX |
| Jun 8, 1999 | K991288 | DISTENDER SERIES II BAROSTAT G & J Electronics, Inc., CA | FFX |
| Jun 4, 1999 | K973844 | GASTRIC AND RECTAL CATHETERS G & J Electronics, Inc., CA | FFX |
| May 12, 1999 | K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 Sandhill Scientific, Inc. | FFX |
| Feb 4, 1999 | K981733 | DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 Medtronic Functional Diagnostics A/S, DK | FFX |
| Jan 11, 1999 | K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 Sandhill Scientific, Inc. | FFX |
| Jun 15, 1998 | K980980 | MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 Konigsberg Instruments, Inc. | FFX |
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