510(k) K140588

FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS by Stryker Corporation — Product Code FXY

K140588 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS". The FDA issued a decision of Substantially Equivalent on June 26, 2014. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. Stryker Corporation has at least 10 other 510(k) clearances on record.