510(k) K261234

The D-Tip Denudation Pipette by Allwin Medical Devices, Inc. — Product Code MQH

K261234 is an FDA 510(k) premarket notification submitted by Allwin Medical Devices, Inc. for the device "The D-Tip Denudation Pipette". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Allwin Medical Devices, Inc. has 7 other 510(k) clearances on record.