510(k) K231261

Altaviz Needle Kit II by Altaviz, LLC — Product Code FMI

K231261 is an FDA 510(k) premarket notification submitted by Altaviz, LLC for the device "Altaviz Needle Kit II". The FDA issued a decision of Substantially Equivalent on July 27, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Altaviz, LLC has at least 2 other 510(k) clearances on record.