# K103509: Unimax Suction Irrigation Set

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Systems, Inc.
- Decided: May 19, 2011 after 171 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: 2 generations back to K963646 (1997). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041967: Genicon Suction Irrigation System, Genicon (2004) Summary page 3.

## Most influential descendants
- K192643: Dannik Laparoscopic Suction Irrigation System (2019), 2 descendants of its own
- K141592: Unimicro Suction Irriation Tubing Set (2014), 2 descendants of its own
- K222575: HurriChem Device Kit (2022), 1 descendant of its own
- K150253: Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm (2015), 1 descendant of its own
- K243867: LAGIS Suction Irrigation System (2025), 0 descendants of its own

## Indications for use
The Unimax Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology 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/K103509
Methodology: https://510kreport.com/methodology