FDA.reportPublic FDA data

510(k) K183619

Device
Tactra Penile Prosthesis, 9.5 Mm Device, Tactra Penile Prosthesis, 11 Mm Device, Tactra Penile Prosthesis, 13 Mm Device
Applicant
Boston Scientific Corporation
510(k) number
K183619
Product code
FAE  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-16
Date received
2018-12-26
Regulation
876.3630
Classification name
Prosthesis, Penile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Laura Kelly
Address
10700 Bren Rd. W. Minnetonka MN US 55343 55343

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181673Rigi10 Malleable Penile ProsthesisRigicon, Inc.2019-04-15
K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.2009-04-09
K082006AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.2008-10-20
K040959MENTOR GENESIS PENILE PROSTHESISMentor Corp.2004-10-29
K963328AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.1996-12-04
K953640DUNA II PENILE PROSTHESISDacomed Corp.1995-10-27
K951716AMS 650 MALLERABLE PENIEL PROSTHESISAmerican Medical Systems, Inc.1995-07-06
K920420DURA II PENILE PROSTHESISDacomed Corp.1992-04-16
K912935AMS MALLEABLE 600 AND 600M PENILE PROSTHESISAmerican Medical Systems, Inc.1992-03-18
K912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISDacomed Corp.1991-10-11
K910214AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESISAmerican Medical Corp.1991-04-25
K904262MINNOW PENILE IMPLANT PROTECTORRuja-Med Medical Marketing1990-12-13
K900371MENTOR MODIFIED MALLEABLE PENILE PROSTHESESMentor Corp.1990-11-02
K901482700 ULTREX PENILE PROSTHESIS 12MM DIAMETERAmerican Medical Systems, Inc.1990-06-27
K896941AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESISAmerican Medical Systems, Inc.1990-03-06