Mediplus Single Use Lower Gi Manometry Catheter

FDA 510(k) K031617 · Mediplus , Ltd.

Substantially Equivalent

510(k) numberK031617

Submission

Device name
Mediplus Single Use Lower Gi Manometry Catheter
Applicant
Mediplus , Ltd.
Potomac, MD, US
Received
May 23, 2003
Decision date
January 16, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KLA

510(k)DeviceApplicantDecision
K242666Fecobionics Anorectal SystemKLA · Traditional Gi Bionics, LLC02/12/2025SE
K242304RedKLA · Traditional Neuraxis, Inc.12/06/2024SE
K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA · Traditional Laborie Medical Technologies, Corp.04/23/2024SE
K180135THD Anopress with THD SensyProbeKLA · Traditional Thd Spa03/08/2018SE
K161785THD AnopressKLA · Traditional Thd Spa03/14/2017SE
K143031mcompass Biofeedback Anorectal Manometry SystemKLA · Traditional Medspira, LLC07/07/2015SE
K120088Mcompass Anorectal Manometry SystemKLA · Traditional Medspira, LLC03/29/2012SE
K062362Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersKLA · Traditional Sarmed Srl04/13/2007SE
K032138Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…KLA · Traditional Medtronic Vascular10/09/2003SE
K022023Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional Clinical Innovations, Inc.01/07/2003SE

More from Clinical Innovations, Inc.

510(k)DeviceDecision
K132890Suprapubic Catheter and Introducer SetKOB · Traditional 01/17/2014SE
K131339CapnomaskCCK · Traditional 11/25/2013SE
K013704Mediplus Single Use Gi Manometry CatheterKLA · Traditional 08/05/2002SE

Questions and answers

When was Mediplus Single Use Lower Gi Manometry Catheter cleared by the FDA?

Mediplus Single Use Lower Gi Manometry Catheter (K031617) received a 510(k) decision of Substantially Equivalent on January 16, 2004, 238 days after the submission was received.

What is the product code of K031617?

The FDA product code is KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube, a Class II (moderate risk) device regulated under 21 CFR 876.1725.