# K253165: LAP-iX2N

- Pathway: 510(k) (Traditional)
- Applicant: Sejong Medical Co., Ltd.
- Decided: Jun 9, 2026 after 256 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 K934828 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200639: LAP-iX, Sejong Medical Co., Ltd. (2021) Summary page 5.

## Indications for use
LAP-iX2N is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

Source page: https://510kreport.com/device/K253165
Methodology: https://510kreport.com/methodology