# K023808: Irrigation Sets

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Mar 10, 2003 after 116 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Baxter Healthcare Corporation Irrigation Sets: named in the summary without a submission number

## Indications for use
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

Source page: https://510kreport.com/device/K023808
Methodology: https://510kreport.com/methodology