510(k) K243409

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) by Karl Storz SE & CO. KG — Product Code FBO

K243409 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.