Cleared Traditional

K924713 - UNIVERSAL SURGICAL INSTRUMENT HOLDER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K924713 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device
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May 1993
Decision
241d
Days
Class 1
Risk

K924713 is an FDA 510(k) clearance for the UNIVERSAL SURGICAL INSTRUMENT HOLDER. Classified as Table, Operating-room, Pneumatic (product code FWW), Class I - General Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 241 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 T. Korossurgical Instruments Corp. devices

Submission Details

510(k) Number K924713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date May 17, 1993
Days to Decision 241 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
127d slower than avg
Panel avg: 114d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWW Table, Operating-room, Pneumatic
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.