FDA Product Code
FDA Product Code FFX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1725
510(k) Clearances — 70 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System | Mui Scientific, Inc. | 2026-09-30 | Special | PDF ↗ |
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | 2025-12-05 | Traditional | PDF ↗ |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024-05-06 | Traditional | PDF ↗ |
| K231861 | EndoflipTM 300 System | Covidien, LLC | 2023-07-21 | Special | PDF ↗ |
| K223705 | EndoflipTM 300 | Covidien, LLC | 2023-04-14 | Traditional | PDF ↗ |
| K222000 | Transit-Pellets | Medifactia AB | 2023-01-18 | Traditional | PDF ↗ |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | 2020-05-21 | Special | PDF ↗ |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp | 2019-12-18 | Traditional | PDF ↗ |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | 2019-10-03 | Traditional | PDF ↗ |
| K181760 | Transit-Pellets | Medifactia AB | 2019-08-08 | Traditional | PDF ↗ |
| K183072 | EndoFLIP System | Crospon, Ltd. | 2019-02-15 | Traditional | PDF ↗ |
| K181750 | SITZMARKS | Konsyl Pharmaceuticals | 2018-11-15 | Traditional | PDF ↗ |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | 2017-04-17 | Special | PDF ↗ |
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017-03-14 | Traditional | PDF ↗ |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016-06-20 | Special | PDF ↗ |
| K160725 | EndoFLIP | Crospon, Ltd. | 2016-05-01 | Traditional | PDF ↗ |
| K151086 | ManoScan System | Given Imaging , Ltd. | 2016-04-28 | Traditional | PDF ↗ |
| K130906 | ENDOFLIP CATHETER | Crospon, Ltd. | 2013-07-17 | Traditional | PDF ↗ |
| K122294 | PRESSURIZED INFUSION PUMP | Mui Scientific | 2012-11-01 | Traditional | PDF ↗ |
| K120997 | BAROSTAT SOFTWARE OPTION | Crospon, Ltd. | 2012-08-27 | Traditional | PDF ↗ |
| K121014 | SOLAR GI | Medical Measurement Systems B.V. | 2012-08-01 | Traditional | PDF ↗ |
| K120524 | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM | Mui Scientific | 2012-06-21 | Traditional | PDF ↗ |
| K102214 | ENDO FLIP | Crospon, Ltd. | 2010-12-16 | Traditional | PDF ↗ |
| K102801 | PHTIP DISPOSABLE ISFET CATHETER | E-Cath Co., Ltd. | 2010-10-26 | Traditional | PDF ↗ |
| K092850 | ENDOFLIP | Crospon, Ltd. | 2009-12-15 | Traditional | PDF ↗ |
| K091070 | MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM | Sierra Scientific Instruments, Inc. | 2009-05-19 | Traditional | PDF ↗ |
| K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 | Life-Tech, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K071094 | MODIFICATION TO SOLAR GI | Medical Measurement Systems B.V. | 2007-08-13 | Traditional | PDF ↗ |
| K062222 | UNITIP HIGH RESOLUTION CATHETER | Unisensor AG | 2007-03-15 | Traditional | PDF ↗ |
| K060166 | OHMEGA | Medical Measurement Systems B.V. | 2006-04-21 | Traditional | PDF ↗ |
| K052338 | SOLAR GI | Medical Measurement Systems B.V. | 2005-12-15 | Special | PDF ↗ |
| K031084 | SOLAR GI SYSTEM | Medical Measurement Systems B.V. | 2004-03-19 | Traditional | PDF ↗ |
| K031169 | MOTILITY VISUALIZATION SYSTEM | Sierra Scientific Instruments, Inc. | 2003-12-12 | Traditional | PDF ↗ |
| K011471 | BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER | Medtronic Functional Diagnostics A/S | 2002-11-08 | Traditional | PDF ↗ |
| K012232 | INSIGHT, MODEL S980000 | Sandhill Scientific, Inc. | 2002-06-07 | Traditional | PDF ↗ |
| K013154 | MARK II/MARK III MANOMETRIC PERFUSION PUMP | Dentsleeve Pty., Ltd. | 2001-10-19 | Special | PDF ↗ |
| K011472 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID | Medtronic Functional Diagnostics A/S | 2001-08-10 | Traditional | PDF ↗ |
| K003580 | UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER | Unisensor AG | 2001-07-31 | Abbreviated | PDF ↗ |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 | Sandhill Scientific, Inc. | 2001-06-22 | Abbreviated | PDF ↗ |
| K004040 | REDTECH GIPC 2000 | Red-Tech, Inc. | 2001-03-29 | Traditional | PDF ↗ |
| K010130 | POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 | Medtronic Functional Diagnostics A/S | 2001-02-07 | Special | PDF ↗ |
| K000386 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 | Medtronic Functional Diagnostics A/S | 2000-05-05 | Traditional | PDF ↗ |
| K992713 | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 | Medtronic Functional Diagnostics A/S | 1999-11-10 | Traditional | PDF ↗ |
| K991389 | ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 | Medtronic Functional Diagnostics A/S | 1999-07-15 | Traditional | PDF ↗ |
| K991288 | DISTENDER SERIES II BAROSTAT | G & J Electronics, Inc. | 1999-06-08 | Traditional | PDF ↗ |
| K973844 | GASTRIC AND RECTAL CATHETERS | G & J Electronics, Inc. | 1999-06-04 | Traditional | PDF ↗ |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | Sandhill Scientific, Inc. | 1999-05-12 | Traditional | PDF ↗ |
| K981733 | DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 | Medtronic Functional Diagnostics A/S | 1999-02-04 | Traditional | PDF ↗ |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | Sandhill Scientific, Inc. | 1999-01-11 | Special | PDF ↗ |
| K980980 | MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 | Konigsberg Instruments, Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K980946 | MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP | Dentsleeve Pty., Ltd. | 1998-06-08 | Traditional | PDF ↗ |
| K972439 | ANORECTAL MANOMETRY ANALYSIS MODULE | Medtronic-Synectics | 1997-09-23 | Traditional | PDF ↗ |
| K963064 | ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM | Laborie Medical Tech Corp. | 1997-06-05 | Traditional | PDF ↗ |
| K942247 | SMALL BOWEL ANALYSIS SOFTWARE | Sandhill Scientific, Inc. | 1996-04-09 | Traditional | PDF ↗ |
| K921682 | ZINETICS AMC | Zinetics Medical, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K932306 | MICROINFUSOR | Sandhill Scientific, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K920664 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION | Diagnostic Ultrasound Corp. | 1993-12-23 | Traditional | PDF ↗ |
| K921062 | GAELTEC MPR SERIES | Medical Measurements, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K905154 | GASTROSCAN | Medics Instrument Corp. | 1991-06-19 | Traditional | PDF ↗ |
| K900058 | WILSON-COOK BILIARY MOTILITY CATHETER | Wilson-Cook Medical, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K880581 | AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. | Synectics-Dantec | 1988-08-11 | Traditional | PDF ↗ |
| K881609 | SITZMARKS | Lafayette Pharmacal, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K874690 | GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER | Mentor Corp. | 1988-02-08 | Traditional | PDF ↗ |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | Narco Bio-Systems | 1983-10-31 | Traditional | PDF ↗ |
| K831347 | MICROCAPILLARY INFUSION SYSTEM | J.S. Biomedicals, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K830421 | SYN-02 PN AMPLIFIER | Biosearch Medical Products, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K823701 | MOTILITY CATHETERS | Mui Scientific | 1983-02-15 | Traditional | PDF ↗ |
| K812103 | ESOPHAGEAL MOTILITY APPARATUS | Honeywell, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K780812 | ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 | Honeywell, Inc. | 1978-06-13 | Traditional | PDF ↗ |
| K760761 | ESOPHAGEAL MOTILITY TUBE | Sherwood Medical Industries | 1976-11-30 | Traditional | PDF ↗ |
Product code FFX · Class II · Gastroenterology, Urology. Data: openFDA.