510(k) K062918

KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM by KARL STORZ Endoscopy-America, Inc. — Product Code FBO

K062918 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 2007. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.