Cleared Traditional

K193612 - AMT Suture Delivery System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193612 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Mar 2020
Decision
77d
Days
Class 2
Risk

K193612 is an FDA 510(k) clearance for the AMT Suture Delivery System. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on March 12, 2020 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Medical Technology, Inc. devices

Submission Details

510(k) Number K193612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date March 12, 2020
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGC Tube, Gastro-enterostomy
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.