510(k) K173316

SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device by Transmed7, LLC — Product Code KNW

K173316 is an FDA 510(k) premarket notification submitted by Transmed7, LLC for the device "SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device". The FDA issued a decision of Substantially Equivalent on Jun 19, 2018. 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.