510(k) K901482

700 ULTREX PENILE PROSTHESIS 12MM DIAMETER by American Medical Systems, Inc. — Product Code FAE

K901482 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "700 ULTREX PENILE PROSTHESIS 12MM DIAMETER". The FDA issued a decision of Substantially Equivalent on June 27, 1990. 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.