510(k) Report

Devices descending from K971244

6 later devices reach Provox 2 Voice Prosthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090455Provox Vega, Model 8130-8135Atos Medical AB20092—
+1K043138Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134Atos Medical AB20040—
+1K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc.19991—
+2K131947Provox Vega Puncture SetAtos Medical AB20131—
+2K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC20080—
+3K240763FirstFit Surgical KitFreudenberg Medical, LLC20240—