510(k) K210946

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles by Promisemed Hangzhou Meditech Co., Ltd. — Product Code KNW

K210946 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles". The FDA issued a decision of Substantially Equivalent on Aug 12, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Promisemed Hangzhou Meditech Co., Ltd. has 35 other 510(k) clearances on record.