510(k) K212822

Disposable Coaxial Biopsy Needle by Suzhou Leapmed Healthcare Corporation — Product Code FCG

K212822 is an FDA 510(k) premarket notification submitted by Suzhou Leapmed Healthcare Corporation for the device "Disposable Coaxial Biopsy Needle". The FDA issued a decision of Substantially Equivalent on July 6, 2022. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Suzhou Leapmed Healthcare Corporation has at least 3 other 510(k) clearances on record.