Cleared Traditional

K033591 - REPROCESSED TROCARS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K033591 · Clearmedical, Inc. · Ear, Nose, Throat device
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Jun 2005
Decision
568d
Days
Class 1
Risk

K033591 is an FDA 510(k) clearance for the REPROCESSED TROCARS. Classified as Trocar, Sinus (product code KBG), Class I - General Controls.

Submitted by Clearmedical, Inc. (Bellevue, US). The FDA issued a Cleared decision on June 3, 2005 after a review of 568 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Clearmedical, Inc. devices

Submission Details

510(k) Number K033591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date June 03, 2005
Days to Decision 568 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
479d slower than avg
Panel avg: 89d · This submission: 568d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KBG Trocar, Sinus
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.