510(k) Report

Devices descending from K940638

2 later devices reach Provox (TM) Voice Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131947Provox Vega Puncture SetAtos Medical AB20131—
+2K240763FirstFit Surgical KitFreudenberg Medical, LLC20240—