510(k) K242128

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) by Xaga Surgical — Product Code KNW

K242128 is an FDA 510(k) premarket notification submitted by Xaga Surgical for the device "Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)". The FDA issued a decision of Substantially Equivalent on February 27, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.