510(k) Report

Devices descending from K073552

10 later devices reach Laborie Urodynamic System with Tetra Accessory through their predicates, nearest generation first.

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