510(k) K171956

Sterile Endoscope Biopsy Sampling Needle by Changzhou Detain Medical Devices Co., Ltd. — Product Code FCG

K171956 is an FDA 510(k) premarket notification submitted by Changzhou Detain Medical Devices Co., Ltd. for the device "Sterile Endoscope Biopsy Sampling Needle". The FDA issued a decision of Substantially Equivalent on December 12, 2017. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075.