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AMT Initial Placement GI Kit (E2418) and AMT Dilator Set (E2419)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K073034

by Applied Medical Technology, Inc.

Identifiers

510(k) Number
K073034 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
SESK Substantially Equivalent — Kit FDA 510(k)

The AMT Initial Placement GI Kit (E2418) and AMT Dilator Set (E2419) are procedural kits classified as gastrointestinal tubes and accessories. The kit is designed for the initial placement of a percutaneous gastrostomy device, including incremental dilation of the gastric stoma using a dilator set.

These devices are intended for clinical use by healthcare professionals and are supplied as single-use kits. The AMT Initial Placement GI Kit (E2418) and AMT Dilator Set (E2419) have received FDA 510(k) clearance (K073034) and comply with the EU Medical Device Regulation (MDR). No specific MRI safety or sterility details are provided in the data.

Frequently asked questions

What is the primary purpose of the AMT Initial Placement GI Kit and Dilator Set, and who should use them?

The AMT Initial Placement GI Kit (E2418) and AMT Dilator Set (E2419) are designed specifically for the initial placement of a percutaneous gastrostomy (feeding tube) device. They include tools for creating and gradually dilating the gastric stoma, ensuring safe and controlled access. These kits are intended exclusively for use by trained healthcare professionals, such as gastroenterologists or surgeons, during procedural placements.

Are these kits meant for single-use or can they be reused?

The AMT Initial Placement GI Kit and Dilator Set are explicitly labeled as single-use kits. This designation ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure, as reuse could compromise device integrity and introduce infection risks.

What regulatory pathways have these devices undergone, and where are they approved for use?

The AMT Initial Placement GI Kit (E2418) and Dilator Set (E2419) have received FDA 510(k) clearance under the reference number K073034, indicating compliance with U.S. regulatory standards for gastrointestinal tubes and accessories. Additionally, they comply with the EU Medical Device Regulation (MDR), allowing use within the European market. No specific MRI safety information is provided.

How are these kits supplied, and what should I consider when storing them?

The kits are supplied as complete, pre-packaged procedural sets, including all necessary components for initial gastrostomy placement and dilation. While sterility details are not explicitly stated, the single-use nature implies they should be stored in a clean, dry environment, protected from contamination, and used within the manufacturer’s recommended shelf life. Always follow facility protocols for sterile supply handling.

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: Amt Initial Placement Gi Kit (E2418) and Amt Dilator Set (E2419), www.accessdata.fda.gov, fda.innolitics.com, PDF AMT Initial Placement Dilator Set, PDF AMT PEG-Assist® Initial Placement GI Kit

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (2)

  • FDA 510(k) K073034 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026