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KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube Class II

FDA Device Classification

Classification Details

Product Code
KLA
Device Class
Class II
Regulation Number
876.1725
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242666gi bionicsFecobionics Anorectal SystemFebruary 12, 2025
K242304neuraxisREDDecember 6, 2024
K234107laborie medical technologiesSolar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)April 23, 2024
K180135thdTHD Anopress with THD SensyProbeMarch 8, 2018
K161785thdTHD ANOPRESSMarch 14, 2017
K143031medspiramcompass Biofeedback Anorectal Manometry SystemJuly 7, 2015
K120088medspiraMCOMPASS ANORECTAL MANOMETRY SYSTEMMarch 29, 2012
K062362sarmedSINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CAApril 13, 2007
K031617mediplusMEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETERJanuary 16, 2004
K032138medtronic vascularMEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECOctober 9, 2003
K022023clinical innovationsCOMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURJanuary 7, 2003
K013704mediplusMEDIPLUS SINGLE USE GI MANOMETRY CATHETERAugust 5, 2002
K983665dentsleeve ptyMANOMETRIC ASSEMBLIESMay 17, 1999
K964804oakfield instrumentsFLEXILOG LSAugust 6, 1997
K964589oakfield instrumentsFLEXILOG 3000March 4, 1997
K961895oakfield instrumentsFLEXILOG LS 13921November 4, 1996
K961070synectics medicalESOPHAGEAL MANOMETRY ANALYSIS MODULEJune 11, 1996
K961056sandhill scientificBIOVIEW MODEL S960000June 6, 1996
K954798kay elemetrics7100 SWALLOWING WORKSTATIONJune 4, 1996
K941801sandhill scientificANALGRAPHSeptember 8, 1995