# K250900: EvoEndo Single-Use Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: EvoEndo, Inc.
- Decided: Jun 16, 2025 after 83 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931154 (1993). 39 ancestors in all.
No later device cites it as a predicate yet.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213606: EvoEndo Single-Use Endoscopy System, EvoEndo, Inc. (2022) Summary page 6.

## Indications for use
The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single-use device and can be inserted orally or transnasally. The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

Source page: https://510kreport.com/device/K250900
Methodology: https://510kreport.com/methodology