510(k) Report

Devices descending from K082701

8 later devices reach Uronirs, Model 2000 through their predicates, nearest generation first.

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