# K040094: Piggyback Irrigating System

- Pathway: 510(k) (Abbreviated)
- Applicant: Kosin Technologies, LLC
- Decided: Apr 15, 2004 after 90 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
Longest line of descent: 1 generation back to K905102 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905102: Bard (R) Syringe Assist Irrigation, C.R. Bard, Inc. (1991) Summary page 1.

## Indications for use
The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

Source page: https://510kreport.com/device/K040094
Methodology: https://510kreport.com/methodology