FDA 510(k) Applications for Medical Device Product Code: KLA (Monitor, Esophageal Motility, And Tube)

FDA 510(k) Applications for Medical Device Product Code "KLA"
(Monitor, Esophageal Motility, And Tube)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K022023	CLINICAL INNOVATIONS, INC.	COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500	01/07/2003
K983665	DENTSLEEVE PTY., LTD.	MANOMETRIC ASSEMBLIES	05/17/1999
K242666	GI Bionics, LLC	Fecobionics Anorectal System	02/12/2025
K954798	KAY ELEMETRICS CORP.	7100 SWALLOWING WORKSTATION	06/04/1996
K234107	Laborie Medical Technologies Corp.	SolarÖ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)	04/23/2024
K013704	MEDIPLUS LTD.	MEDIPLUS SINGLE USE GI MANOMETRY CATHETER	08/05/2002
K031617	MEDIPLUS LTD.	MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER	01/16/2004
K120088	MEDSPIRA, LLC	MCOMPASS ANORECTAL MANOMETRY SYSTEM	03/29/2012
K143031	MEDSPIRA, LLC	mcompass Biofeedback Anorectal Manometry System	07/07/2015
K032138	MEDTRONIC VASCULAR	MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER	10/09/2003
K242304	NeurAxis, Inc	RED	12/06/2024
K964589	OAKFIELD INSTRUMENTS, LTD.	FLEXILOG 3000	03/04/1997
K964804	OAKFIELD INSTRUMENTS, LTD.	FLEXILOG LS	08/06/1997
K961895	OAKFIELD INSTRUMENTS, LTD.	FLEXILOG LS 13921	11/04/1996
K961056	SANDHILL SCIENTIFIC, INC.	BIOVIEW MODEL S960000	06/06/1996
K062362	SARMED SRL	SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS	04/13/2007
K961070	SYNECTICS MEDICAL, INC.	ESOPHAGEAL MANOMETRY ANALYSIS MODULE	06/11/1996
K161785	THD SPA	THD ANOPRESS	03/14/2017
K180135	THD SpA	THD Anopress with THD SensyProbe	03/08/2018