510(k) K943668

KSEA CONTINOUS FLOW CYSTOSCOPE by KARL STORZ Endoscopy-America, Inc. — Product Code FBO

K943668 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA CONTINOUS FLOW CYSTOSCOPE". The FDA issued a decision of Substantially Equivalent on September 21, 1994. 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.