510(k) K945185

CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) by KARL STORZ Endoscopy-America, Inc. — Product Code FBO

K945185 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)". The FDA issued a decision of Substantially Equivalent on May 3, 1995. 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.