FFX · Class II · 21 CFR 876.1725

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

Leading manufacturers include Wilson-Cook Medical, Inc., Medifactia AB and Anx Robotica Corp.

69
Total
69
Cleared
179d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 109d recently vs 180d historically

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

69 devices
1–24 of 69
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 Jun 20, 2016
Lehman Manometry Catheter
K160170
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jul 27, 1990
WILSON-COOK BILIARY MOTILITY CATHETER
K900058
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 205d
Cleared Feb 08, 1988
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690
Mentor Corp.
Gastroenterology & Urology · 84d
Cleared Apr 06, 1983
SYN-02 PN AMPLIFIER
K830421
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY APPARATUS
K812103
Honeywell, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 13, 1978
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812
Honeywell, Inc.
Gastroenterology & Urology · 27d
Cleared Nov 30, 1976
ESOPHAGEAL MOTILITY TUBE
K760761
Sherwood Medical Industries
Gastroenterology & Urology · 57d

About Product Code FFX - Regulatory Context

510(k) Submission Activity

69 total 510(k) submissions under product code FFX since 1976, with 69 receiving FDA clearance (average review time: 179 days).

Submission volume has declined in recent years - 1 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 109 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 →