# K192643: Dannik Laparoscopic Suction Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Dannik
- Decided: Nov 19, 2019 after 56 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: 3 generations back to K963646 (1997). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103509: Unimax Suction Irrigation Set, Unimax Medical Systems, Inc. (2011) Summary page 4.

## Most influential descendants
- K222575: HurriChem Device Kit (2022), 1 descendant of its own
- K231622: REGER Nebulizer Irrigation Cannula (2023), 0 descendants of its own

## Indications for use
The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site

Source page: https://510kreport.com/device/K192643
Methodology: https://510kreport.com/methodology