EvoEndo, Inc. · Class II · Cleared Apr 21, 2026
| K-number | K260573 |
| Device name | EvoEndo Single-Use Endoscopy System |
| Applicant | EvoEndo, Inc. |
| Product code | FDS |
| Device class | Class II |
| Decision date | Apr 21, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The EvoEndo Single-Use Endoscopy System is a sterile, single-use gastroscope intended for visualization and diagnosis of the upper digestive tract (esophagus, stomach, duodenal bulb) in adults and pediatric patients via oral or transnasal insertion. The system includes a 110 cm or 85 cm endoscope with an integrated HD camera, a reusable video cable, and a controller unit that displays the captured images on a medical-grade monitor.
The subject device has the same outer diameter (3.5 mm), working channel diameter (2.0 mm), working length (110 cm and 85 cm), field of view (120°), steering method (4-way), and bending angles as the predicate device. The key difference is the shaft design: the subject device uses a multi-lumen braid-reinforced Pebax construction versus the predicate's multi-lumen extrusion. Additionally, the subject device's video cable is labeled as reusable versus the predicate's single-use designation, supported by cleaning and disinfection validation.
Not stated in this summary.
The subject device is substantially equivalent to the predicate device (K251708) because it is intended for the same indications for use, maintains identical external dimensions and functional specifications, and involves no design or manufacturing changes except for the video cable reusability labeling, which was supported by cleaning and disinfection validation. The predicate device has a demonstrated history of safe use with no known unmitigated safety issues or design-related recalls.
View the full FDA submission: accessdata.fda.gov