510(k) Report

Devices descending from K881680

8 later devices reach Ackrad H/S Procedure Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020954H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…Ackrad Laboratories20027—
+2K110993Femchec Pressure Managemet DeviceFemasys, Inc.20110—
+2K110288Femvue Saline-Air DeviceFemasys, Inc.20115—
+3K242002FemVue MINI Saline-Air DeviceFemasys, Inc.20240—
+3K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.20241—
+3K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc.20150—
+3K143415Air Bubble Based Infuser (ABBI)CooperSurgical, Inc.20150—
+4K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.20250—