# K212296: Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Aug 19, 2021 after 28 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: 6 generations back to K993704 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193123: FUJIFILM Distal Cap Models 33-40, Fujifilm Corporation (2019) Summary page 4.

## Indications for use
Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.

Source page: https://510kreport.com/device/K212296
Methodology: https://510kreport.com/methodology