Mediplus Single Use Lower GI Manometry Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031617 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)
The Mediplus Single Use Lower GI Manometry Catheter is a device used for water-perfused manometry of the anorectal GI tract. It is designed to measure gastrointestinal tract pressures to assist in the diagnosis of suspected colonic and anorectal disorders. This catheter is classified as a monitor for esophageal motility and is intended for single use.
The device is supplied as a single-use catheter and is not intended for reuse. It is regulated under FDA 510(k) clearance with product code KLA and was determined to be substantially equivalent. The device is manufactured by Mediplus, Ltd. and is intended for use in gastroenterology and urology settings.
Frequently asked questions
What is the Mediplus Single Use Lower GI Manometry Catheter used for?
This catheter is designed for water-perfused manometry of the anorectal GI tract, measuring gastrointestinal tract pressures to assist in diagnosing suspected colonic and anorectal disorders in gastroenterology and urology settings.
Is the Mediplus Lower GI Manometry Catheter reusable?
No, this device is supplied as a single-use catheter and is not intended for reuse. Each catheter should be discarded after a single procedure to ensure patient safety and accurate results.
What are the regulatory specifications for this device?
The Mediplus Single Use Lower GI Manometry Catheter is regulated under FDA 510(k) clearance with product code KLA and was determined to be substantially equivalent. It is classified as a monitor for esophageal motility and received clearance in 2004.
How is the Mediplus Lower GI Manometry Catheter supplied?
The device is supplied as a single-use catheter ready for immediate use in clinical settings. It is manufactured by Mediplus, Ltd. and intended for use in gastroenterology and urology procedures requiring measurement of anorectal GI tract pressures.
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 LOWER GI MANOMETRY CATHETER by MEDIPLUS LTD. | FDA ..., Mediplus Single Use Lower Gi Manometry Catheter, MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (K013704) — FDA 510(k ..., MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER 510 (k) K031617 - FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031617 | Class II | Active |
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Manufacturer
- Manufacturer
- Mediplus , Ltd.
Sources (1)
- FDA 510(k) K031617 24 fields · synced Sep 22, 2026