510(k) K201244

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices by Transmed7, LLC — Product Code KNW

K201244 is an FDA 510(k) premarket notification submitted by Transmed7, LLC for the device "Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices". The FDA issued a decision of Substantially Equivalent on Aug 7, 2020. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Transmed7, LLC has 1 other 510(k) clearance on record.