510(k) K183035

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle by Cook Incorporated — Product Code LJE

K183035 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle". The FDA issued a decision of Substantially Equivalent (kit) on May 17, 2019. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Cook Incorporated has at least 10 other 510(k) clearances on record.