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Single Use GI Manometry Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013704

by Mediplus , Ltd.

Identifiers

510(k) Number
K013704 FDA 510(k)
FDA Product Code
KLA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1725 FDA 510(k)
Regulation Number
876.1725 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Monitor, Esophageal Motility, Anorectal Motility, and Tube (per FDA nomenclature KLA), designed for water-perfused manometry of the gastrointestinal (GI) tract. It measures pressures within the esophagus, anorectal region, and other sections of the GI tract to aid in diagnosing motility disorders, functional abnormalities, or suspected colonic/anorectal conditions.

The Single Use GI Manometry Catheter is supplied as a sterile, single-use device intended for clinical use in gastroenterology and urology settings. It is classified as a Class II medical device under FDA regulations (21 CFR 876.1725) and has received FDA 510(k) clearance (K013704) as substantially equivalent to a predicate device. Storage and handling follow standard aseptic protocols for single-use diagnostic catheters, ensuring sterility and functionality for one-time patient use.

Frequently asked questions

What clinical specialties primarily use this manometry catheter, and why is it designed for them?

This catheter is primarily used in gastroenterology and urology settings. It is designed for these specialties because it measures pressures in the esophagus, anorectal region, and other sections of the GI tract, helping diagnose motility disorders, functional abnormalities, or suspected colonic/anorectal conditions. Its water-perfused manometry function provides detailed pressure readings critical for evaluating gastrointestinal and anorectal motility.

Is this device reusable, or is it intended for single-use only? How does that affect its sterility and handling?

This device is sterile and intended for single-use only. Because it is designed for one-time patient use, it follows aseptic protocols during storage and handling to maintain sterility and functionality. Reusing it would violate these protocols and could compromise patient safety, so proper disposal after use is required.

What types of gastrointestinal conditions can this catheter help diagnose, and how does it work?

This catheter helps diagnose motility disorders, functional abnormalities, and suspected colonic/anorectal conditions by measuring pressures within the esophagus, anorectal region, and other GI sections. It uses water-perfused manometry, a technique that infuses water into the catheter’s channels to detect pressure changes, allowing clinicians to assess how well the GI tract moves food, air, and waste.

How is this device regulated in the U.S., and what does its FDA clearance status mean for buyers?

This device has received FDA 510(k) clearance (K013704), meaning it is classified as substantially equivalent to a predicate device under 21 CFR 876.1725 (Class II). This clearance confirms that the device meets FDA safety and effectiveness requirements for esophageal and anorectal motility monitoring, giving buyers confidence in its regulatory compliance and clinical reliability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (K013704) — FDA 510(k ..., MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER by MEDIPLUS LTD. | FDA ..., Mediplus Single Use Lower Gi Manometry Catheter, MEDIPLUS SINGLE USE GI MANOMETRY CATHETER 510(k)… - FDA.report, Promoting Management and Leadership - HealthManagement.org

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mediplus , Ltd.

Sources (1)

  • FDA 510(k) K013704 24 fields · synced Sep 19, 2026