510(k) K200248

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators by Allwin Medical Devices, Inc. — Product Code MQF

K200248 is an FDA 510(k) premarket notification submitted by Allwin Medical Devices, Inc. for the device "Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators". The FDA issued a decision of Substantially Equivalent on July 1, 2020. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Allwin Medical Devices, Inc. has at least 6 other 510(k) clearances on record.