510(k) Report

Devices descending from K931574

11 later devices reach Advance Model Uds-Adv through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073552Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp.200810—
+2K212830CT3000ProSrs Medical20210—
+2K082701Uronirs, Model 2000Urodynamix Technologies, Ltd.20088—
+3K120088Mcompass Anorectal Manometry SystemMedspira, LLC201271
+4K180135THD Anopress with THD SensyProbeThd Spa20183—
+4K161785THD AnopressThd Spa20174—
+4K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC201511
+5K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC20250—
+5K242666Fecobionics Anorectal SystemGi Bionics, LLC20250—
+5K242304REDNeuraxis, Inc.20240—
+5K211623THD Procto Software SystemThd Spa20210—