Cleared Traditional

K934744 - MIDMARK MAGNUM GENERAL SURGICAL TABLE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K934744 · Midmark Corp. · General & Plastic Surgery device
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Mar 1994
Decision
175d
Days
Class 1
Risk

K934744 is an FDA 510(k) clearance for the MIDMARK MAGNUM GENERAL SURGICAL TABLE. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 175 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - 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 Midmark Corp. devices

Submission Details

510(k) Number K934744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date March 28, 1994
Days to Decision 175 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
61d slower than avg
Panel avg: 114d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDC Table, Operating-room, Electrical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.