510(k) K131364

FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE by KARL STORZ Endoscopy-America, Inc. — Product Code FBO

K131364 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE". The FDA issued a decision of Substantially Equivalent on January 2, 2014. 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.