Cleared Traditional

AMT T-FASTENER ANCHOR KIT (K120587) - FDA 510(k) Clearance

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

K120587 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
88d
Days
Class 2
Risk

K120587 is an FDA 510(k) clearance for the AMT T-FASTENER ANCHOR KIT. 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 May 25, 2012 after a review of 88 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 K120587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 27, 2012
Decision Date May 25, 2012
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
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.

Regulatory Peers - KGC Tube, Gastro-enterostomy

All 25
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K120587.
PUMA-G Pediatric System
K242211 · Coaptech, Inc. · Apr 2025
PUMA-G System
K223916 · Coaptech, Inc. · Mar 2023
AMT Suture Delivery System
K193612 · Applied Medical Technology, Inc. · Mar 2020
Fidmi Low Profile Enteral Feeding Device
K191844 · Fidmi Medical, Ltd. · Sep 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · Cook Incorporated · Jun 2019
PUMA-G System
K183057 · Coaptech, LLC · Apr 2019