510(k) K212820

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

K212820 is an FDA 510(k) premarket notification submitted by Suzhou Leapmed Healthcare Corporation for the device "Disposable Semi Automatic Biopsy Instrument". The FDA issued a decision of Substantially Equivalent on July 6, 2022. 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.