510(k) K251860

Copioumed AAMI 3 Surgical Gown by Copioumed International, Inc. — Product Code FYA

K251860 is an FDA 510(k) premarket notification submitted by Copioumed International, Inc. for the device "Copioumed AAMI 3 Surgical Gown". The FDA issued a decision of Substantially Equivalent on February 26, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Copioumed International, Inc. has at least 1 other 510(k) clearance on record.