510(k) K190590

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) by Allwin Medical Devices, Inc. — Product Code MQE

K190590 is an FDA 510(k) premarket notification submitted by Allwin Medical Devices, Inc. for the device "Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)". The FDA issued a decision of Substantially Equivalent on November 25, 2019. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Allwin Medical Devices, Inc. has at least 6 other 510(k) clearances on record.