# K063316: Fujinon Model EG-530N Trans Nasal Insertion

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Mar 16, 2007 after 134 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: 2 generations back to K944759 (1995). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5, Fujinon, Inc. (2004) Summary page 2.

## Most influential descendants
- K182836: FUJIFILM Endoscope Model EG-740N (2019), 4 descendants of its own
- K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (2024), 3 descendants of its own
- K213606: EvoEndo Single-Use Endoscopy System (2022), 3 descendants of its own
- K251708: EvoEndo Single-Use Endoscopy System (2025), 1 descendant of its own
- K243260: FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (2025), 1 descendant of its own

## Indications for use
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

Source page: https://510kreport.com/device/K063316
Methodology: https://510kreport.com/methodology