# K142629: EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: May 14, 2015 after 240 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: 3 generations back to K944759 (1995). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 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 4.
- K112391: Fujinon Colonoscopes, Fujinon, Inc. (2012) Summary page 4.

## Most influential descendants
- K210162: Endoscope Model EI-740D/S (2021), 5 descendants of its own
- K221551: FUJIFILM Endoscope Model EI-740D/S (2023), 2 descendants of its own
- K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (2026), 0 descendants of its own
- K260824: Gastrointestinal Videoscope Olympus GIF-2T1500 (2026), 0 descendants of its own
- K253702: Intuitive Endoluminal Gastrointestinal System (IG1000) (2026), 0 descendants of its own

## Indications for use
The Fujifilm Endoscopes: EG-530CT, EG-530D, EC-530DL, and ES-530WE have the following indications for use: Indications for Use (EG-530CT): The EG-530CT Endoscope: This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Indications for Use (EG-530D): The EG-530D Endoscope: This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Indications for Use (EC-530DL): The EC-530DL Endoscope: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Indications for Use (ES-530WE): The ES-530WE Endoscope: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.

Source page: https://510kreport.com/device/K142629
Methodology: https://510kreport.com/methodology