510(k) K910214

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS by American Medical Corp. — Product Code FAE

K910214 is an FDA 510(k) premarket notification submitted by American Medical Corp. for the device "AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. American Medical Corp. has at least 2 other 510(k) clearances on record.