# K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporaton
- Decided: Jan 11, 2023 after 77 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: 5 generations back to K993704 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183683: FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5, Fujifilm Corporation (2019) Summary page 4.
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.
- K213195: Balloon BS-3, Fujifilm Corporation (2021) Summary page 4.

## Most influential descendants
- K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C (2024), 0 descendants of its own

## Indications for use
Endoscope EN-580T This device is 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. Never use this product for any other purposes. Over-tube TS-1314B This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children. Balloon BS-4 This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children. Tube Kit TY-500D This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.

Source page: https://510kreport.com/device/K223295
Methodology: https://510kreport.com/methodology