Cleared Traditional

K841165 - ELECTRO SURGERY SYSTEM

K841165 is an FDA 510(k) clearance for ELECTRO SURGERY SYSTEM, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K841165 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery device
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Jun 1984
Decision
78d
Days
Class 1
Risk

K841165 is an FDA 510(k) clearance for the ELECTRO SURGERY SYSTEM. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on June 5, 1984 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Aire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K841165

510(k) Number K841165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date June 05, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
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 18
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K841165.
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K842475 · Richards Medical Co., Inc. · Sep 1984
RICHARDS INTRA-ARTICULAR SHAVER BLADES
K830153 · Richard'S Medical Equip., Inc. · Feb 1983