Cleared Traditional

K900583 - MODIFIED BIVONA EPISTAXIS CATHETER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K900583 · Bivona Medical Technologies · Ear, Nose, Throat device
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Aug 1990
Decision
183d
Days
Class 1
Risk

K900583 is an FDA 510(k) clearance for the MODIFIED BIVONA EPISTAXIS CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 183 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

Submission Details

510(k) Number K900583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date August 09, 1990
Days to Decision 183 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 89d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
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.