510(k) Report

Devices descending from K953640

2 later devices reach Duna II Penile Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090663Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.20090—
+1K082006Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.20081—