# K171096: Fujifilm Diathermic Slitter (FlushKnife)

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: May 9, 2017 after 26 days
- Product code: KGE (Forceps, Biopsy, Electric)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955052 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161186: Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter), Fujifilm Medical Systems U.S.A, Inc. (2016) Summary page 4.

## Most influential descendants
- K220053: Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (2022), 0 descendants of its own

## Indications for use
Diathermic Slitter (FlushKnife) DK2618J and DK2623J are intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The devices are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

Source page: https://510kreport.com/device/K171096
Methodology: https://510kreport.com/methodology