510(k) Report

Devices descending from K930105

2 later devices reach Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc.19991—
+2K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC20080—