510(k) Report

Devices descending from K031169

15 later devices reach Motility Visualization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142355Vaginal Tactile ImagerAdvanced Tactile Imaging, Inc.20151—
+1K120088Mcompass Anorectal Manometry SystemMedspira, LLC201271
+1K091070Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc.20091—
+1K062222Unitip High Resolution CatheterUnisensor AG20072—
+2K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.20240—
+2K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare201901
+2K180135THD Anopress with THD SensyProbeThd Spa20183—
+2K161785THD AnopressThd Spa20174—
+2K151086ManoScan SystemGiven Imaging, Ltd.20160—
+2K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC201511
+2K102801Phtip Disposable Isfet CatheterE-Cath Co., Ltd.20100—
+3K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC20250—
+3K242666Fecobionics Anorectal SystemGi Bionics, LLC20250—
+3K242304REDNeuraxis, Inc.20240—
+3K211623THD Procto Software SystemThd Spa20210—