Cleared Traditional

L.T.C. REPLACEMENT GASTROSTOMY TUBE (K896621) - FDA 510(k) Clearance

Class I Dental device.

K896621 · Intl. Medical Marketing, Inc. · Dental device
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Mar 1990
Decision
112d
Days
Class 1
Risk

K896621 is an FDA 510(k) clearance for the L.T.C. REPLACEMENT GASTROSTOMY TUBE. Classified as Tube Impression And Matrix (product code KCQ), Class I - General Controls.

Submitted by Intl. Medical Marketing, Inc. (Ridge, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6570 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Medical Marketing, Inc. devices

Submission Details

510(k) Number K896621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date March 13, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCQ Tube Impression And Matrix
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6570
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.