EvoEndo, Inc. · Class II · Cleared Oct 10, 2025
| K-number | K251708 |
| Device name | EvoEndo Single-Use Endoscopy System |
| Applicant | EvoEndo, Inc. |
| Product code | FDS |
| Device class | Class II |
| Decision date | Oct 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The EvoEndo Single-Use Endoscopy System is a sterile, single-use gastroscope designed for visualization and diagnosis of the upper digestive tract in adults and pediatric patients. It consists of a flexible endoscope (available in 110 cm and 85 cm lengths), a reusable video cable, and a controller unit. The device enables oral or transnasal insertion for observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.
The subject device features a 3.5 mm outer diameter, 2.0 mm working channel, 120° field of view, and 4-way steering with enhanced maximum bending angles (Left/Right 180° vs. predicate's 100°). The shaft design changed from multi-lumen extrusion to multi-lumen braid-reinforced Pebax. The controller firmware now includes image enhancement (gamma correction) and user-programmable functions, whereas the predicate offered only image/video capture and white-balance reset. Packaging changed from thermoform tray to plastic card with HDPE tube. Shelf life extended from 6 to 12 months.
ISO 10993-1 (biocompatibility evaluation), IEC/TR 62471 (photobiological safety), IEC 60601-1 Ed. 3.2 en:2020 (electrical safety), IEC 60601-1-2:2014/AMD1:2020 (EMC), IEC 60601-2-18:2009 (endoscope-specific safety), and FDA Guidance on Off-The-Shelf Software Use in Medical Devices (August 2023).
The subject device is substantially equivalent to the predicate (K213606) because both are single-use gastroscopes with identical indications for use, same outer diameter and working channel, same field of view and steering method, and equivalent or superior deflection capabilities in all directions. Design changes (braid-reinforced shaft, enhanced firmware features, improved packaging, extended shelf life) represent iterative improvements that do not alter the fundamental intended use or safety/effectiveness profile. Comprehensive biocompatibility, functional, electrical safety, and usability testing all met acceptance criteria, and no unmitigated safety issues were identified with the predicate device.
View the full FDA submission: accessdata.fda.gov