Fujifilm Corporation · Class II · Cleared Jun 10, 2025
| K-number | K243512 |
| Device name | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP |
| Applicant | Fujifilm Corporation |
| Product code | FDS |
| Device class | Class II |
| Decision date | Jun 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The FUJIFILM Endoscope Models EG-840N, EG-840T, and EG-840TP are upper digestive tract endoscopes used for visualization, observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. The EG-840N model can be inserted orally or nasally, while the EG-840T and EG-840TP models are inserted orally.
The subject devices have the same intended use, indications for use, technological characteristics, and materials as the predicate device, with differences only in delayed reprocessing instructions and software version. The devices feature a bending portion, flexible tube with operating channels, distal end with imaging section, CMOS image sensor, light guide system, and control section with forceps inlet and scope connector.
Electrical safety (ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2020, IEC 60601-1-6:2020, IEC 60601-2-18:2009), biocompatibility (ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010), endoscope-specific testing (ISO 8600-1:2015, ISO 8600-3:2019, ISO 8600-4:2014), and software validation (IEC 62304:2015).
The subject devices are substantially equivalent to the predicate because they share identical intended use, indications, technological characteristics, and materials. The differences in delayed reprocessing instructions and software version do not raise new safety or effectiveness issues, as validated through cleaning/disinfection/sterilization testing and software/cybersecurity evaluation demonstrating substantial equivalence in performance to the predicate device.
View the full FDA submission: accessdata.fda.gov