510(k) Report

Devices descending from K110288

5 later devices reach Femvue Saline-Air Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242002FemVue MINI Saline-Air DeviceFemasys, Inc.20240—
+1K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.20241—
+1K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc.20150—
+1K143415Air Bubble Based Infuser (ABBI)CooperSurgical, Inc.20150—
+2K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.20250—