510(k) K262531

OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver by Teleflex Medical, LLC — Product Code KNW

K262531 is an FDA 510(k) premarket notification submitted by Teleflex Medical, LLC for the device "OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver". The FDA issued a decision of Substantially Equivalent on Oct 27, 2026. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Teleflex Medical, LLC has 42 other 510(k) clearances on record.