510(k) Report

Devices descending from K013972

5 later devices reach H/S Elliptosphere Catheter Set, Model 61-4005 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083594EZ HSG Catheter.Foamseal CatheterObg Products20092—
+1K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc.20070—
+1K021272Sib Catheter, Model 61-7005Ackrad Laboratories20020—
+2K180300Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated20181—
+3K222798Rejoni Intrauterine CatheterRejoni, Inc.20220—