510(k) K951716

AMS 650 MALLERABLE PENIEL PROSTHESIS by American Medical Systems, Inc. — Product Code FAE

K951716 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS 650 MALLERABLE PENIEL PROSTHESIS". The FDA issued a decision of Substantially Equivalent on July 6, 1995. 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.