510(k) K972979

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM by Smith & Nephew, Inc. — Product Code FBO

K972979 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM". The FDA issued a decision of Substantially Equivalent on December 11, 1997. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.