510(k) K181993

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) by Sturdy Industrial Co., Ltd. — Product Code FLE

K181993 is an FDA 510(k) premarket notification submitted by Sturdy Industrial Co., Ltd. for the device "STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)". The FDA issued a decision of Substantially Equivalent on November 1, 2019. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Sturdy Industrial Co., Ltd. has at least 2 other 510(k) clearances on record.