510(k) K214063

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle by Guangzhou Shengwei Medical Devices Co., Ltd. — Product Code KNW

K214063 is an FDA 510(k) premarket notification submitted by Guangzhou Shengwei Medical Devices Co., Ltd. for the device "Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle". The FDA issued a decision of Substantially Equivalent on Jun 3, 2022. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.