Cleared Traditional

DEXIDE LAPAROSCOPIC KITS (K924117) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K924117 · Dexide, Inc. · General & Plastic Surgery device
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Mar 1993
Decision
221d
Days
Class 1
Risk

K924117 is an FDA 510(k) clearance for the DEXIDE LAPAROSCOPIC KITS. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Dexide, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 221 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.

View all Dexide, Inc. devices

Submission Details

510(k) Number K924117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 14, 1992
Decision Date March 23, 1993
Days to Decision 221 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
106d slower than avg
Panel avg: 115d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
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.