# K243867: LAGIS Suction Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Lagis Enterprise Co., Ltd.
- Decided: Mar 17, 2025 after 90 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K963646 (1997). 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)
- K150253: Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm, Taiwan Surgical Corporation (2015) Summary page 6.

## Indications for use
The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

Source page: https://510kreport.com/device/K243867
Methodology: https://510kreport.com/methodology