510(k) K050488

TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES by Prosurg, Inc. — Product Code FAS

K050488 is an FDA 510(k) premarket notification submitted by Prosurg, Inc. for the device "TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES". The FDA issued a decision of Substantially Equivalent on April 1, 2005. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Prosurg, Inc. has at least 10 other 510(k) clearances on record.