Cleared Traditional

UNIQUET (K931198) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K931198 · Icat Systems · General & Plastic Surgery device
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Sep 1993
Decision
176d
Days
Class 1
Risk

K931198 is an FDA 510(k) clearance for the UNIQUET. Classified as Tourniquet, Nonpneumatic (product code GAX), Class I - General Controls.

Submitted by Icat Systems (San Leandro, US). The FDA issued a Cleared decision on September 1, 1993 after a review of 176 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5900 - 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 K931198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date September 01, 1993
Days to Decision 176 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: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAX Tourniquet, Nonpneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5900
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.