Cleared Traditional

K913266 - MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS

K913266 is an FDA 510(k) clearance for MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/T..., manufactured by Micro Surgical Instruments Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913266 · Micro Surgical Instruments Corp. · General & Plastic Surgery device
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Oct 1991
Decision
90d
Days
Class 1
Risk

K913266 is an FDA 510(k) clearance for the MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS. 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 October 21, 1991 after a review of 90 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

FDA 510(k) Submission Details - K913266

510(k) Number K913266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1991
Decision Date October 21, 1991
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

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.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 26
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K913266.
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MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033 · Micro-Aire Surgical Instruments, Inc. · Feb 1990
THE DEXTRA PRECISION POWER UNIT
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DRILLING TEMPLATE
K853761 · Orthopedic Systems, Inc. · Oct 1985