Cleared Traditional

K123716 - AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FE...

K123716 is the FDA 510(k) clearance for AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FE... by Applied Medical Technology, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K123716 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Apr 2013
Decision
136d
Days
Class 2
Risk

K123716 is an FDA 510(k) clearance for the AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT. 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 April 19, 2013 after a review of 136 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

Submission Details

510(k) Number K123716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 04, 2012
Decision Date April 19, 2013
Days to Decision 136 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 130d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 253
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