# K252457: Disposable Distal End Tape Hood

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Decided: Jan 30, 2026 after 178 days
- Product code: FDF (Colonoscope 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.
No later device cites it as a predicate yet.
0 of 9 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 7.

## Indications for use
This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection. This product needs to be cut and connected to the endoscope tip of φ9mm to φ 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.

Source page: https://510kreport.com/device/K252457
Methodology: https://510kreport.com/methodology