# K973734: Sterile Water for Device Irrigation/ Sterile Saline for Device Irrigation

- Pathway: 510(k) (Traditional)
- Applicant: Welcon, Inc.
- Decided: Feb 5, 1998 after 128 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- 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 K842166 (1985). 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)
- K842166: Intermed, Ins Sterile Water/Saline, Intermed, Inc. (1985) Summary page 1.

## Indications for use
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.

Source page: https://510kreport.com/device/K973734
Methodology: https://510kreport.com/methodology