510(k) K172763

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder by Zhejiang Kindly Medical Devices Co., Ltd. — Product Code JKA

K172763 is an FDA 510(k) premarket notification submitted by Zhejiang Kindly Medical Devices Co., Ltd. for the device "Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder". The FDA issued a decision of Substantially Equivalent on June 4, 2018. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Zhejiang Kindly Medical Devices Co., Ltd. has at least 4 other 510(k) clearances on record.