# K041967: Genicon Suction Irrigation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Genicon
- Decided: Nov 12, 2004 after 114 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: 1 generation back to K963646 (1997). 1 ancestor in all.
9 later devices descend from it; 1 cites 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)
- K963646: Stryker Strykeflow Suction Irrigator Gravity Flow, Stryker Endoscopy (1997) Summary page 1.

## Most influential descendants
- K103509: Unimax Suction Irrigation Set (2011), 8 descendants of its own
- 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

## Indications for use
The GeniCon Laparoscopic Suction/Irrigation System 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/K041967
Methodology: https://510kreport.com/methodology