510(k) K212284

Disposable Automatic Core Biopsy Instrument by Suzhou Leapmed Healthcare Corporation — Product Code KNW

K212284 is an FDA 510(k) premarket notification submitted by Suzhou Leapmed Healthcare Corporation for the device "Disposable Automatic Core Biopsy Instrument". The FDA issued a decision of Substantially Equivalent on November 10, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Suzhou Leapmed Healthcare Corporation has at least 3 other 510(k) clearances on record.