510(k) K183619

Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device by Boston Scientific Corporation — Product Code FAE

K183619 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device". The FDA issued a decision of Substantially Equivalent on April 16, 2019. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.