510(k) Report

Devices descending from K130273

4 later devices reach Panpac Vaginal Dilators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose20230—
+1K211959Milli Vaginal DilatorMaterna Medical20212—
+2K220035Milli Vaginal DilatorMaterna Medical20231—
+3K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose20240—