# K220053: Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Feb 4, 2022 after 29 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: 5 generations back to K955052 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171096: Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Medical Systems U.S.A, Inc. (2017) Summary page 4.

## Indications for use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.

Source page: https://510kreport.com/device/K220053
Methodology: https://510kreport.com/methodology