510(k) Report

Devices descending from K083690

6 later devices reach Femvue (TM) Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc.20150—
+1K123258The Advance Catheter for HSG and SisCatheter Research, Inc.20133—
+1K100662Femvue Cornual Balloon CatheterFemasys, Inc.20100—
+2K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated20190—
+2K160217uVue HSG/SHG CatheterCook Incorporated20161—
+3K180291Cook Silicone Balloon HSG CatheterCook Incorporated20180—