510(k) Report

Devices descending from K011472

16 later devices reach Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151086ManoScan SystemGiven Imaging, Ltd.20160—
+1K031169Motility Visualization SystemSierra Scientific Instruments, Inc.2003151
+2K142355Vaginal Tactile ImagerAdvanced Tactile Imaging, Inc.20151—
+2K120088Mcompass Anorectal Manometry SystemMedspira, LLC201271
+2K091070Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc.20091—
+2K062222Unitip High Resolution CatheterUnisensor AG20072—
+3K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.20240—
+3K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare201901
+3K180135THD Anopress with THD SensyProbeThd Spa20183—
+3K161785THD AnopressThd Spa20174—
+3K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC201511
+3K102801Phtip Disposable Isfet CatheterE-Cath Co., Ltd.20100—
+4K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC20250—
+4K242666Fecobionics Anorectal SystemGi Bionics, LLC20250—
+4K242304REDNeuraxis, Inc.20240—
+4K211623THD Procto Software SystemThd Spa20210—