510(k) Report

Devices descending from K020954

7 later devices reach H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110993Femchec Pressure Managemet DeviceFemasys, Inc.20110—
+1K110288Femvue Saline-Air DeviceFemasys, Inc.20115—
+2K242002FemVue MINI Saline-Air DeviceFemasys, Inc.20240—
+2K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.20241—
+2K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc.20150—
+2K143415Air Bubble Based Infuser (ABBI)CooperSurgical, Inc.20150—
+3K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.20250—