510(k) K083330

ECHOTIP ULTRA ULTRASOUND NEEDLE by Cook Endoscopy — Product Code FCG

K083330 is an FDA 510(k) premarket notification submitted by Cook Endoscopy for the device "ECHOTIP ULTRA ULTRASOUND NEEDLE". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Cook Endoscopy has at least 3 other 510(k) clearances on record.