# K173405: DiLumen Endolumenal Interventional Scissors (DiLumen Is)

- Pathway: 510(k) (Traditional)
- Applicant: Lumendi, LLC
- Decided: May 22, 2018 after 203 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: 3 generations back to K910831 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061425: Purewrist Scissors, Model PW1101-01;Purewrist Dissector,  Model PW1201-01;Purewrist Hook, Model PW1301-01, Cambridge Endoscopic Devices (2006) Summary page 4.

## Most influential descendants
- K183112: DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) (2019), 0 descendants of its own

## Indications for use
The DiLumen Endolumenal Interventional Scissors (“DiLumen Is™”) is a disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.

Source page: https://510kreport.com/device/K173405
Methodology: https://510kreport.com/methodology