# K982435: Irrigation Syringe Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sub-Q, Inc.
- Decided: Nov 6, 1998 after 116 days
- Product code: KYZ (Syringe, Irrigating (Non Dental))
- Device class: 1
- Regulation: 21 CFR 880.6960
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

Source page: https://510kreport.com/device/K982435
Methodology: https://510kreport.com/methodology