FDA.reportPublic FDA data

510(k) K181673

Device
Rigi10 Malleable Penile Prosthesis
Applicant
Rigicon Inc.
510(k) number
K181673
Product code
FAE  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-15
Date received
2018-06-25
Regulation
876.3630
Classification name
Prosthesis, Penile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ahmet Melih Luleci
Address
150 Motor Pkwy. S401 Hauppauge NY US 11788 11788

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
K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceBoston Scientific Corporation2019-04-16
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