# K261544: Hydro Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jun 17, 2026 after 40 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 K013838 (2002). 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)
- K013838: Ksea Clearvision Lens Irrigation System, KARL STORZ Endoscopy-America, Inc. (2002) 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 otolaryngology procedures.

Source page: https://510kreport.com/device/K261544
Methodology: https://510kreport.com/methodology