# K253679: Hydro Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: May 8, 2026 after 168 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902683 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072410: Ksea Clearvision II, Model 40334120, KARL STORZ Endoscopy-America, Inc. (2008) Summary page 5.

## Indications for use
The Hydro Irrigation Console (console) and its accessories (also referred to as the Hydro Irrigation System) are intended for cleaning the distal lens of rigid endoscopes and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.

Source page: https://510kreport.com/device/K253679
Methodology: https://510kreport.com/methodology