510(k) K261037

780 nm SPY Portable Handheld Imaging (SPY-PHI) System by Stryker Endoscopy — Product Code IZI

K261037 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "780 nm SPY Portable Handheld Imaging (SPY-PHI) System". The FDA issued a decision of Substantially Equivalent on May 28, 2026. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Stryker Endoscopy has at least 10 other 510(k) clearances on record.