510(k) K223689

Disposable Needle Guides and Grids by Advance Medical Designs, Inc. — Product Code ITX

K223689 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "Disposable Needle Guides and Grids". The FDA issued a decision of Substantially Equivalent on August 2, 2023. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.