510(k) K072521

COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH by Cook Urological, Inc. — Product Code FFS

K072521 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH". The FDA issued a decision of Substantially Equivalent on November 20, 2007. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.