Cleared Traditional

K896621 - L.T.C. REPLACEMENT GASTROSTOMY TUBE

K896621 is an FDA 510(k) clearance for L.T.C. REPLACEMENT GASTROSTOMY TUBE, manufactured by Intl. Medical Marketing, Inc.. The device is a Class 1 Dental device with product code KCQ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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

FDA 510(k) Submission Details - K896621

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.

KCQ Device Classification - Class 1, General Controls

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.