FFX

System, Gastrointestinal Motility (Electrical)

Product code
FFX
Device name
System, Gastrointestinal Motility (Electrical)
Device class
Class 2
21 CFR
21 CFR 876.1725
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
69 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-12-05.

NumberDecision dateApplicantDevice nameSummary
K2526052025-12-05Medspira, LLCmcompass Anorectal Balloon Expulsion Catheter (RMD-0…PDF
K2400072024-05-06Laborie Medical Technologies, Corp.Solar Compact (G4-1)PDF

2 summaries are archived here for direct download.

Official FDA classification page: FFX
Classification and pathway per current FDA publications. Data from openFDA (CC0).