Panels › Gastroenterology, Urology › Product code FFX · Class 2
System, Gastrointestinal Motility (Electrical)
Regulation 876.1725
2510(k)s in 12 months (70 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in FFX
| Company | 510(k)s | Recalls |
|---|---|---|
| Crospon, Ltd. | 7 | 0 |
| Medtronic Functional Diagnostics A/S | 7 | 0 |
| Sandhill Scientific, Inc. | 6 | 1 |
| Medical Measurement Systems B.V. | 5 | 0 |
| Mui Scientific | 5 | 0 |
| Covidien, LLC | 2 | 1 |
| Diversatek Healthcare | 1 | 2 |
| Sierra Scientific Instruments, Inc. | 2 | 1 |
| Anx Robotica Corp | 2 | 0 |
| Dentsleeve Pty., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Covidien, LLC EndoFLIP System that includes:
ENDOFLIP 1 SYSTEM EF-100
05391530810050
10884521809307
REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1
10884521808096
05391530810166
DL ENDOFLIP 1
10884521786684 Open, Classified |
FFX | K183072 |
| Jul 2, 2026 | Laborie Medical Technologies Corp Solar GI System (Water Perfusion);
Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley syste Open, Classified |
FFX | K121014 |
| Aug 14, 2025 | Diversatek Healthcare Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 Open, Classified |
FFX | K190208 |
| Sep 7, 2023 | Diversatek Healthcare ZVU Functional GI Software, REF: ZVU-3 Open, Classified |
FFX | K012232 |
| May 7, 2012 | Sandhill Scientific, Inc Insight rev H software.
The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal stud Terminated |
FFX | K012232 |
| Oct 28, 2011 | Sierra Scientific Instruments Inc AR ManoShield, MSS-3599, 10 pack.
FGS: MSS-3599,
Individual package label: LBL-110275-03,
Box label: LBL-110282-03,
Package Inserts: DOC-3682,
User Manual: DOC-1332-12.
Product Usage: The MVS disp Terminated |
FFX | K031169 |
| Jul 20, 2004 | Medtronic Gastroenterology / Urology Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081 Terminated |
FFX | K981733 |
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