Cleared Traditional

K183508 - Micro Transgastric-Jejunal Feeding Device

K183508 is an FDA 510(k) clearance for Micro Transgastric-Jejunal Feeding Device, manufactured by Applied Medical Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K183508 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
101d
Days
Class 2
Risk

K183508 is an FDA 510(k) clearance for the Micro Transgastric-Jejunal Feeding Device. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Medical Technology, Inc. devices

FDA 510(k) Submission Details - K183508

510(k) Number K183508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 18, 2018
Decision Date March 29, 2019
Days to Decision 101 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 131d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K183508.
Entuit PEG, Entuit PEGJ
K183336 · Wilson-Cook Medical, Inc. · May 2019
Medline Quick-Clear Wand
K183577 · Medline Industries, Inc. · May 2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
K190114 · Convatec Limited · Apr 2019
Traditional Length GJ Feeding Device
K182804 · Applied Medical Technology, Inc. · Mar 2019
ENvizion Medical ENvue
K182915 · Envizion Medical , Ltd. · Feb 2019
Aspire Venting Tube
K182248 · Aspire Bariatrics, Inc. · Nov 2018