# K242927: Suction Irrigation Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Advamedix, GmbH
- Decided: Nov 22, 2024 after 59 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)
- K141592: Unimicro Suction Irriation Tubing Set, Unimicro Medical Systems (Shenzhen) Co., Ltd. (2014) Summary page 5.

## Indications for use
The Disposable Suction Irrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.

Source page: https://510kreport.com/device/K242927
Methodology: https://510kreport.com/methodology