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Monarch Transshaping Gastrostomy Tube Model 9-2010

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012476

by Applied Medical Technology, Inc.

Identifiers

510(k) Number
K012476 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Monarch Transshaping Gastrostomy Tube Model 9-2010 is a percutaneous replacement device for established gastrostomy tracts, facilitating enteral nutrition delivery and gastric decompression in patients unable to consume nutrition orally. It is a type of gastrointestinal tube and accessory. The device is used to maintain access to the stomach via an existing stoma. It functions as a replacement device in clinical settings. The device is classified as a Tube, Gastrointestinal (And Accessories).

The Monarch Transshaping Gastrostomy Tube Model 9-2010 is supplied with a product code of KNT and is regulated under 876.5980. It has been assigned a 510(k) number, K012476, and was found to be Substantially Equivalent. The device is used by healthcare providers in clinical settings and is intended for patients with established gastrostomy tracts. The device is a single model, Model 9-2010.

Frequently asked questions

What is the Monarch Transshaping Gastrostomy Tube used for?

The Monarch Transshaping Gastrostomy Tube is used to maintain access to the stomach via an existing stoma, facilitating enteral nutrition delivery and gastric decompression in patients unable to consume nutrition orally.

Is the Monarch Transshaping Gastrostomy Tube a single-use device?

The device is intended as a replacement device in clinical settings, implying it is designed for reuse in established gastrostomy tracts.

What regulatory classification does the Monarch Transshaping Gastrostomy Tube have?

The device is classified as a Tube, Gastrointestinal (And Accessories) and is regulated under 876.5980 with a product code of KNT.

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: Monarch, Transshaping Gastrostomy Tube Model 9-2010, MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010… - FDA.report, Capsule Monarch® Non Balloon G Tube, Traditional Length - AMT

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (1)

  • FDA 510(k) K012476 24 fields · synced Oct 6, 2026