Cleared Traditional

K942025 - BURGET NASAL STENT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K942025 · Bivona Medical Technologies · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 1995
Decision
549d
Days
Class 1
Risk

K942025 is an FDA 510(k) clearance for the BURGET NASAL STENT. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 549 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 874.3900 - 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 Bivona Medical Technologies devices

Submission Details

510(k) Number K942025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1994
Decision Date October 27, 1995
Days to Decision 549 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
460d slower than avg
Panel avg: 89d · This submission: 549d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWF Dilator, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3900
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.