510(k) K252012

SPY Cystoscope/Hysteroscope by Stryker Endoscopy — Product Code HIH

K252012 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "SPY Cystoscope/Hysteroscope". The FDA issued a decision of Substantially Equivalent on July 18, 2025. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Stryker Endoscopy has at least 10 other 510(k) clearances on record.