# K993704: Gastro-Intestinal System EN-410WM

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Feb 11, 2000 after 101 days
- Product code: FDA (Enteroscope And Accessories)
- 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
No predicates in its family tree.
65 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040048: Fujinon Double Balloon Enteroscopy System (2004), 64 descendants of its own
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), 45 descendants of its own
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (2015), 19 descendants of its own
- K052084: Endo-Ease Endoscopic Overtube (2005), 18 descendants of its own
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (2017), 8 descendants of its own

## Indications for use
This video enteroscope is for the optical visualization of the upper gastrointestinal tract. This includes the Esophagus, Stomach, Duodeum and Small Bowel. It is intended for observation, diagnosis and endoscopic treatment.

Source page: https://510kreport.com/device/K993704
Methodology: https://510kreport.com/methodology