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MTG Instant Cath (With and Without Kit), MTG Instant Cath Deluxe (With and Without Kit)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080878

by Medical Technologies Of Georgia, Inc.

Identifiers

510(k) Number
K080878 FDA 510(k)
FDA Product Code
KOD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MTG Instant Cath is a urological catheter, designed for the temporary drainage of urine from patients. It is classified as a Class II medical device and falls under the FDA’s regulatory category for catheters, intended for use in both urology and gastroenterology procedures. The device is available in standard and deluxe configurations, with the deluxe version including additional features such as an easy-advancer mechanism to reduce slippage during insertion.

The MTG Instant Cath is supplied as a single-use, non-sterile device when not part of a kit, though the kit versions include sterile components. It is intended for use in clinical settings such as hospitals, clinics, or home healthcare environments. The device is regulated under FDA’s 510(k) clearance process, with the original submission dated July 17, 2008, and classified under the product code KOD (Catheters, Urological). No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.

Frequently asked questions

What is the MTG Instant Cath Deluxe used for?

The MTG Instant Cath Deluxe is designed for the temporary drainage of urine in patients. It is intended for use in urological and gastroenterological procedures, providing a reliable solution for short-term urinary catheterization in clinical settings like hospitals, clinics, or home healthcare environments.

How is the MTG Instant Cath supplied, and what are the sterility options?

The MTG Instant Cath is available in both standard and deluxe configurations, with and without a kit. When supplied without a kit, it is non-sterile. However, the kit versions include sterile components, ensuring readiness for immediate clinical use without additional preparation.

Is the MTG Instant Cath intended for single-use or reuse?

The MTG Instant Cath is explicitly designed for single-use. This ensures patient safety by minimizing the risk of infection and contamination, which is critical for medical devices in direct contact with the body.

What distinguishes the deluxe version from the standard MTG Instant Cath?

The deluxe version of the MTG Instant Cath includes an easy-advancer mechanism, which reduces slippage during insertion. This feature enhances usability and patient comfort compared to the standard version, making it particularly suitable for procedures requiring precise placement.

Are there specific storage instructions for the MTG Instant Cath?

The regulatory data does not specify detailed storage conditions for the MTG Instant Cath. However, standard medical device storage practices—such as protecting from extreme temperatures, moisture, and direct sunlight—should be followed. Always refer to the manufacturer’s instructions for the most accurate guidance.

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: Mtg Instant Cather (With and Without Kit), Mtg Instant Cath Deluxe ..., Mtg Instant Cather (with And Without Kit), Mtg Instant Cath Deluxe ..., fda.innolitics.com, MEDICAL TECHNOLOGIES OF GEORGIA, INC. - fda.report, Insta Cath Urinary Catheters - MTG | Piedmont Medical Solutions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Technologies Of Georgia, Inc.

Sources (1)

  • FDA 510(k) K080878 24 fields · synced Oct 5, 2026