Cleared Traditional

SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE (K912418) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K912418 · Micromedics, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
203d
Days
Class 1
Risk

K912418 is an FDA 510(k) clearance for the SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE. Classified as Cannula, Sinus (product code KAM), Class I - General Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 203 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedics, Inc. devices

Submission Details

510(k) Number K912418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date December 20, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAM Cannula, Sinus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.