510(k) K912935

AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS by American Medical Systems, Inc. — Product Code FAE

K912935 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.