Cleared Traditional

K123716 - AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT

K123716 is an FDA 510(k) clearance for AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FE..., 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 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

FDA 510(k) Submission Details - K123716

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 131d · This submission: 136d
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 K123716.
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
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ELECTROMAGNETIC TRANSMITTING STYLET
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MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653 · Kimberly Clark Corporation · Jun 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804 · Hollister, Inc. · Apr 2013
BOEHRINGER GASTRIC SIZING TUBE
K130483 · Boehringer Laboratories, LLC · Mar 2013
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
K123659 · Actuated Medical, Inc. · Dec 2012