Home › Device types › FFX
System, Gastrointestinal Motility (Electrical)
FDA product code FFX · Class 2 · Gastroenterology, Urology
1,347
Registered devices
417
Adverse events
7
Recalls
69
510(k) clearances
Devices with this code
Mui Scientific — H & A Mui Enterprises IncMui Scientific — H & A Mui Enterprises IncinSIGHT Ultima — DIVERSATEK HEALTHCARE, INC.Mui Scientific — H & A Mui Enterprises IncMui Scientific — H & A Mui Enterprises IncMui Scientific — H & A Mui Enterprises IncMui Scientific — H & A Mui Enterprises IncImpedance/pH, 6 imp channels, 1 pH antimony, Adult, 6.4 Fr — Medical Measurement Systems B.V.Mui Scientific — H & A Mui Enterprises IncMui Scientific — H & A Mui Enterprises IncUniTip High Resolution Catheter — Unisensor AGUniTip Catheter — Unisensor AGMui Scientific — H & A Mui Enterprises IncMui Scientific — H & A Mui Enterprises IncUniTip Catheter — Unisensor AGMui Scientific — H & A Mui Enterprises IncUniTip High Resolution Catheter — Unisensor AGUniTip High Resolution Catheter — Unisensor AGDistender II Barostat — G&J Electronics IncUniTip High Resolution Catheter — Unisensor AGMui Scientific — H & A Mui Enterprises IncUniTip Catheter — Unisensor AGUniTip High Resolution Catheter — Unisensor AGMui Scientific — H & A Mui Enterprises Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Laborie Medical Technologies Corp | Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's interna |
| 2026-05-13 | Covidien, LLC | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. |
| 2025-06-04 | Diversatek Healthcare | Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration da |
| 2023-07-25 | Diversatek Healthcare | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| 2011-10-12 | Sierra Scientific Instruments Inc | The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not p |
| 2009-02-23 | Sandhill Scientific, Inc | Software error may produce incorrect esophageal contraction readings. |
| 2004-04-28 | Medtronic Gastroenterology / Urology | Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short. |
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