Cleared Traditional

K935584 - MEDNEXT BUR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K935584 · Mednext, Inc. · Ear, Nose, Throat device
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Feb 1994
Decision
96d
Days
Class 1
Risk

K935584 is an FDA 510(k) clearance for the MEDNEXT BUR. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by Mednext, Inc. (West Point Beach, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - 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 Mednext, Inc. devices

Submission Details

510(k) Number K935584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date February 22, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 89d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
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.