Cleared Traditional

K913369 - MICRO-AIRE MODEL 2060 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K913369 · Micro Surgical Instruments Corp. · General & Plastic Surgery device
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Nov 1991
Decision
95d
Days
Class 1
Risk

K913369 is an FDA 510(k) clearance for the MICRO-AIRE MODEL 2060. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on November 1, 1991 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Micro Surgical Instruments Corp. devices

Submission Details

510(k) Number K913369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date November 01, 1991
Days to Decision 95 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
19d faster than avg
Panel avg: 114d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.