# K974233: Lysonix Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Lysonix, Inc.
- Decided: Feb 3, 1998 after 83 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LySonix Ultrasonic Surgical System: named in the summary without a submission number

## Most influential descendants
- K013417: Misonix Irrigation System Moedl BC20P (2002), 0 descendants of its own

## Indications for use
The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Source page: https://510kreport.com/device/K974233
Methodology: https://510kreport.com/methodology