# K193123: FUJIFILM Distal Cap Models 33-40

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Dec 11, 2019 after 29 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.
2 later devices descend from it; 2 cite 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)
- 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
- K253568: Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (2026), 0 descendants of its own
- K212296: Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 (2021), 0 descendants of its own

## Indications for use
Distal Cap Models DH-33GR, DH-34CR, and DH-40GR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection. Distal Cap Models DH-35GZ, DH-37CZ, DH-38CZ, and DH-39CZ are intended to be used in combination with compatible endoscopes to maintain the field of view during observation of the digestive tract.

Source page: https://510kreport.com/device/K193123
Methodology: https://510kreport.com/methodology