Cleared Traditional

K022743 - REPROCESSED DISPOSABLE TROCARS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K022743 · Medical Device Services · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 2002
Decision
51d
Days
Class 1
Risk

K022743 is an FDA 510(k) clearance for the REPROCESSED DISPOSABLE TROCARS. Classified as Trocar, Laryngeal (product code KAB), Class I - General Controls.

Submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K022743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2002
Decision Date October 09, 2002
Days to Decision 51 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 89d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAB Trocar, Laryngeal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.