FDA 510(k) Applications for Medical Device Product Code: FAE (Prosthesis, Penile)

FDA 510(k) Applications for Medical Device Product Code "FAE"
(Prosthesis, Penile)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K963328	AMERICAN MEDICAL SYSTEMS, INC.	AMS AMBICOR PENILE PROSTHESIS	12/04/1996
K082006	AMERICAN MEDICAL SYSTEMS, INC.	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS	10/20/2008
K090663	AMERICAN MEDICAL SYSTEMS, INC.	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS	04/09/2009
K183619	Boston Scientific Corporation	Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device	04/16/2019
K040959	MENTOR CORP.	MENTOR GENESIS PENILE PROSTHESIS	10/29/2004
K181673	Rigicon Inc.	Rigi10 Malleable Penile Prosthesis	04/15/2019