510(k) K233571

GCI Surgical Gown by George Courey, Inc. — Product Code FYA

K233571 is an FDA 510(k) premarket notification submitted by George Courey, Inc. for the device "GCI Surgical Gown". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. George Courey, Inc. has at least 1 other 510(k) clearance on record.