Cleared Traditional

K073034 - AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)

K073034 is an FDA 510(k) clearance for AMT INITIAL PLACEMENT GI KIT (E2418) AN..., 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 140-day FDA review.

K073034 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Mar 2008
Decision
140d
Days
Class 2
Risk

K073034 is an FDA 510(k) clearance for the AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 140 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.

FDA 510(k) Submission Details - K073034

510(k) Number K073034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 26, 2007
Decision Date March 14, 2008
Days to Decision 140 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
9d slower than avg
Panel avg: 131d · This submission: 140d
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 644
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K073034 · AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
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