Cleared Traditional

3M MAXI-DRIVER II ELECTRIC SYSTEM (K951118) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K951118 · 3M Company · General & Plastic Surgery device
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Jul 1995
Decision
118d
Days
Class 1
Risk

K951118 is an FDA 510(k) clearance for the 3M MAXI-DRIVER II ELECTRIC SYSTEM. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by 3M Company (Burbank, US). The FDA issued a Cleared decision on July 6, 1995 after a review of 118 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.

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Submission Details

510(k) Number K951118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date July 06, 1995
Days to Decision 118 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
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.