Cleared Traditional

K934744 - MIDMARK MAGNUM GENERAL SURGICAL TABLE

K934744 is an FDA 510(k) clearance for MIDMARK MAGNUM GENERAL SURGICAL TABLE, manufactured by Midmark Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

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

FDA 510(k) Submission Details - K934744

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

GDC Device Classification - Class 1, General Controls

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.

Regulatory Peers - GDC Table, Operating-room, Electrical

All 13
Devices cleared under the same product code (GDC) and FDA review panel - the closest regulatory comparables to K934744.
MOBILE OPERATING TABLE 1132.01
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K853720 · Carl Zeiss, Inc. · Oct 1985