Cleared Traditional

K910584 - ONE STEP BUTTON(TM)

K910584 is the FDA 510(k) clearance for ONE STEP BUTTON(TM) by Applied Medical Technologies. It is a Class 2 Gastroenterology & Urology device (product code KGC) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K910584 · Applied Medical Technologies · Gastroenterology & Urology device
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May 1991
Decision
101d
Days
Class 2
Risk

K910584 is an FDA 510(k) clearance for the ONE STEP BUTTON(TM). Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on May 23, 1991 after a review of 101 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 Technologies devices

Submission Details

510(k) Number K910584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1991
Decision Date May 23, 1991
Days to Decision 101 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 130d · This submission: 101d
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 13
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K910584.
MEDLINE GASTROSTOMY TUBE
K073718 · Medline Industries, Inc. · Mar 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · Kimberly-Clark Corp. · Feb 2008
BARD REPLACEMENT GASTROSTOMY TUBE
K910492 · C.R. Bard, Inc. · Jul 1991
BUTTON REPLACEMENT GASTROSTOMY DEVICE
K904779 · C.R. Bard, Inc. · Jan 1991
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
K904801 · Orion Life Systems, Inc. · Jan 1991