510(k) Report

Devices descending from K022023

11 later devices reach Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.20240—
+1K120088Mcompass Anorectal Manometry SystemMedspira, LLC201271
+1K032138Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…Medtronic Vascular20031—
+2K180135THD Anopress with THD SensyProbeThd Spa20183—
+2K161785THD AnopressThd Spa20174—
+2K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC201511
+2K062362Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersSarmed Srl20070—
+3K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC20250—
+3K242666Fecobionics Anorectal SystemGi Bionics, LLC20250—
+3K242304REDNeuraxis, Inc.20240—
+3K211623THD Procto Software SystemThd Spa20210—