# K200638: LAP-iX Suction Irrigation

- Pathway: 510(k) (Special)
- Applicant: Sejong Medical Co., Ltd.
- Decided: Apr 3, 2020 after 24 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903207 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173111: LAP-iX Suction Irrigation, Sejong Medical Co., Ltd. (2017) Summary page 4.

## Indications for use
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.

Source page: https://510kreport.com/device/K200638
Methodology: https://510kreport.com/methodology