# K213606: EvoEndo Single-Use Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: EvoEndo, Inc.
- Decided: Feb 14, 2022 after 91 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: 11 generations back to K931154 (1993). 38 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063316: Fujinon Model EG-530N Trans Nasal Insertion, Fujinon, Inc. (2007) Summary page 5.
- K193202: EXALT Model D Single-Use Duodenoscope, EXALT Controller, Boston Scientific Corporation (2019) Summary page 5.

## Most influential descendants
- K251708: EvoEndo Single-Use Endoscopy System (2025), 1 descendant of its own
- K260573: EvoEndo Single-Use Endoscopy System (2026), 0 descendants of its own
- K250900: EvoEndo Single-Use Endoscopy System (2025), 0 descendants of its own

## 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 in patients over the age of five years. 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/K213606
Methodology: https://510kreport.com/methodology