FDA cleared the Hydro Irrigation System from Stryker Instruments on Jun 17, 2026 under K261544, a traditional 510(k). The device falls under product code EOB, Nasopharyngoscope (Flexible Or Rigid), regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.
FDA logged the submission as received on May 8, 2026. The decision came 40 days later, inside the 90 FDA-day goal for a 510(k).
Stryker Instruments has 4 other decisions in the tracker over the last 12 months: K262244 (Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)), K261959 (Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)), K253679 (Hydro Irrigation System), K252282 (SurgiCount+ System).