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FDA 510(k)

AMT G-Tube Balloon Gastrostomy Feeding Device

K-Number: K222846 · 2023-12-18

ApplicantApplied Medical Technology, Inc.
Decision Date2023-12-18
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT G-Tube Balloon Gastrostomy Feeding Device is a medical device manufactured by Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-12-18 under approval number K222846. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMT G-Tube Balloon Gastrostomy Feeding Device?

AMT G-Tube Balloon Gastrostomy Feeding Device is a medical device that received FDA 510(k) clearance on 2023-12-18. It is manufactured by Applied Medical Technology, Inc.. The 510(k) number is K222846.

When was AMT G-Tube Balloon Gastrostomy Feeding Device approved by the FDA?

AMT G-Tube Balloon Gastrostomy Feeding Device received FDA 510(k) clearance on 2023-12-18, under approval number K222846.

What company makes AMT G-Tube Balloon Gastrostomy Feeding Device?

AMT G-Tube Balloon Gastrostomy Feeding Device is manufactured by Applied Medical Technology, Inc..

What is the FDA product code for AMT G-Tube Balloon Gastrostomy Feeding Device?

The FDA product code for AMT G-Tube Balloon Gastrostomy Feeding Device is KNT.

Related Clinical Trials

NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT05811364 The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease RECRUITING

Other Devices by Applied Medical Technology, Inc.

K170319Low Profile Non-Balloon Feeding Device K161413Low Profile Balloon Feeding Device K180026Bowel Management Device, Bowel Management Irrigation Set K183508Micro Transgastric-Jejunal Feeding Device K182804Traditional Length GJ Feeding Device K202539Nutriglide(TM) Nasal Feeding Tube

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Related Devices (Code: KNT)

K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc. K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd. K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd. K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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