Cleared Traditional

EAST WEST INSTRUMENTS (K941193) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K941193 · East West Instruments, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
243d
Days
Class 1
Risk

K941193 is an FDA 510(k) clearance for the EAST WEST INSTRUMENTS. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by East West Instruments, Inc. (Aurora, US). The FDA issued a Cleared decision on November 9, 1994 after a review of 243 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.

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Submission Details

510(k) Number K941193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1994
Decision Date November 09, 1994
Days to Decision 243 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
128d slower than avg
Panel avg: 115d · This submission: 243d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDM Instrument, Manual, Surgical, General Use
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.