# K232314: Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

- Pathway: 510(k) (Special)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Sep 1, 2023 after 30 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: 5 generations back to K993704 (2000). 8 ancestors in all.
1 later device descends 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)
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR, Fujifilm Medical Systems U.S.A, Inc. (2017) Summary page 4.

## Most influential descendants
- K242779: Hood (DH-083ST) (2024), 0 descendants of its own

## Indications for use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection

Source page: https://510kreport.com/device/K232314
Methodology: https://510kreport.com/methodology