# K183683: FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Feb 27, 2019 after 61 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
Longest line of descent: 4 generations back to K993704 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 4.
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 4.

## Most influential descendants
- K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (2023), 1 descendant of its own
- K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C (2024), 0 descendants of its own

## Indications for use
EN-580T, EN-450P5/20 and EN-450T5 are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum. EC-450BI5 is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.

Source page: https://510kreport.com/device/K183683
Methodology: https://510kreport.com/methodology