510(k) Report

Devices descending from K912935

2 later devices reach Ams Malleable 600 and 600M Penile Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082006Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.20081—
+2K090663Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.20090—