Cleared Traditional

K123716 - AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT (FDA 510(k) Clearance)

K123716 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on April 19, 2013, 136 days after receiving the submission on December 4, 2012.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

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

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5980