# K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Jun 13, 2024 after 258 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: 6 generations back to K993704 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 5.
- K221551: FUJIFILM Endoscope Model EI-740D/S, Fujifilm Corporaton (2023) Summary page 5.
- K183032: FUJIFILM Double Balloon Endoscope EI580BT, Fujifilm Corporation (2019) Summary page 5.
- K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D, Fujifilm Corporaton (2023) Summary page 5.

## Indications for use
Double Balloon Endoscope Model EN-840T 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-1214C This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube. The Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.

Source page: https://510kreport.com/device/K233321
Methodology: https://510kreport.com/methodology