# K183112: DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

- Pathway: 510(k) (Traditional)
- Applicant: Lumendi, LLC
- Decided: Aug 2, 2019 after 267 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K910831 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173405: DiLumen Endolumenal Interventional Scissors (DiLumen Is), Lumendi, LLC (2018) Summary page 4.

## Indications for use
The DiLumen Endolumenal Interventional Knife (“DiLumen IK”) is a disposable monopolar electrosurgical device intended to be used for marking, cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.

Source page: https://510kreport.com/device/K183112
Methodology: https://510kreport.com/methodology