510(k) K951972

CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS by Cabot Medical Corp. — Product Code FBO

K951972 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS". The FDA issued a decision of Substantially Equivalent on July 21, 1995. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.