Cleared Traditional

K832476 - SILICONE SOFT-PAK EPISTAXIS CATHETER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K832476 · Axiom Medical, Inc. · Ear, Nose, Throat device
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Nov 1983
Decision
100d
Days
Class 1
Risk

K832476 is an FDA 510(k) clearance for the SILICONE SOFT-PAK EPISTAXIS CATHETER. Classified as Catheter, Nasopharyngeal (product code ENW), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4175 - 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 Axiom Medical, Inc. devices

Submission Details

510(k) Number K832476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date November 03, 1983
Days to Decision 100 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
11d slower than avg
Panel avg: 89d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ENW Catheter, Nasopharyngeal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4175
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.