FFX · Class II · 21 CFR 876.1725

FDA Product Code FFX: System, Gastrointestinal Motility (electrical)

Leading manufacturers include Crospon, Ltd., Medtronic Functional Diagnostics A/S and Sandhill Scientific, Inc..

70
Total
70
Cleared
177d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 87d recently vs 180d historically

FDA 510(k) Cleared System, Gastrointestinal Motility (electrical) Devices (Product Code FFX)

70 devices
1–24 of 70
Cleared Sep 30, 2026
Rapid Barostat Bag (RBB) Pump and Catheter System
K262621
Mui Scientific, Inc.
Gastroenterology & Urology · 64d
Cleared Dec 05, 2025
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
K252605
Medspira, LLC
Gastroenterology & Urology · 109d
Cleared May 06, 2024
Solar Compact (G4-1)
K240007
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 125d
Cleared Jul 21, 2023
EndoflipTM 300 System
K231861
Covidien, LLC
Gastroenterology & Urology · 28d
Cleared Apr 14, 2023
EndoflipTM 300
K223705
Covidien, LLC
Gastroenterology & Urology · 123d
Cleared Jan 18, 2023
Transit-Pellets
K222000
Medifactia AB
Gastroenterology & Urology · 195d
Cleared May 21, 2020
IntraMarX 3D Radiopaque Marker
K201106
Anx Robotica Corp
Gastroenterology & Urology · 27d
Cleared Dec 18, 2019
IntraMarX Radiopaque Markers
K191087
Anx Robotica Corp
Gastroenterology & Urology · 238d
Cleared Oct 03, 2019
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
K190208
Diversatek Healthcare
Gastroenterology & Urology · 241d
Cleared Aug 08, 2019
Transit-Pellets
K181760
Medifactia AB
Gastroenterology & Urology · 401d
Cleared Feb 15, 2019
EndoFLIP System
K183072
Crospon, Ltd.
Gastroenterology & Urology · 102d
Cleared Nov 15, 2018
SITZMARKS
K181750
Konsyl Pharmaceuticals
Gastroenterology & Urology · 136d
Cleared Apr 17, 2017
EndoFLIP® System with FLIP Topography module
K170833
Crospon, Ltd.
Gastroenterology & Urology · 28d
Cleared Mar 14, 2017
Rapid Barostat Bag (RBB) Pump and Catheter
K160287
Mui Scientific
Gastroenterology & Urology · 405d
Cleared Jun 20, 2016
Lehman Manometry Catheter
K160170
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 145d
Cleared May 01, 2016
EndoFLIP
K160725
Crospon, Ltd.
Gastroenterology & Urology · 46d
Cleared Apr 28, 2016
ManoScan System
K151086
Given Imaging , Ltd.
Gastroenterology & Urology · 372d
Cleared Jul 17, 2013
ENDOFLIP CATHETER
K130906
Crospon, Ltd.
Gastroenterology & Urology · 107d
Cleared Nov 01, 2012
PRESSURIZED INFUSION PUMP
K122294
Mui Scientific
Gastroenterology & Urology · 93d
Cleared Aug 27, 2012
BAROSTAT SOFTWARE OPTION
K120997
Crospon, Ltd.
Gastroenterology & Urology · 147d
Cleared Aug 01, 2012
SOLAR GI
K121014
Medical Measurement Systems B.V.
Gastroenterology & Urology · 120d
Cleared Jun 21, 2012
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
K120524
Mui Scientific
Gastroenterology & Urology · 120d
Cleared Dec 16, 2010
ENDO FLIP
K102214
Crospon, Ltd.
Gastroenterology & Urology · 132d
Cleared Oct 26, 2010
PHTIP DISPOSABLE ISFET CATHETER
K102801
E-Cath Co., Ltd.
Gastroenterology & Urology · 29d

About Product Code FFX - Regulatory Context

510(k) Submission Activity

70 total 510(k) submissions under product code FFX since 1976, with 70 receiving FDA clearance (average review time: 177 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - FFX Product Code

Recent submissions under FFX have taken an average of 87 days to reach a decision - down from 180 days historically, suggesting improved FDA processing for this classification.

FFX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →