510(k) K241793

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle by Zhejiang Curaway Medical Technology Co., Ltd. — Product Code KNW

K241793 is an FDA 510(k) premarket notification submitted by Zhejiang Curaway Medical Technology Co., Ltd. for the device "Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle". The FDA issued a decision of Substantially Equivalent on January 24, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Zhejiang Curaway Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.