Cleared Traditional

K832476 - SILICONE SOFT-PAK EPISTAXIS CATHETER

K832476 is an FDA 510(k) clearance for SILICONE SOFT-PAK EPISTAXIS CATHETER, manufactured by Axiom Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ENW cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

FDA 510(k) Submission Details - K832476

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 89d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

ENW Device Classification - Class 1, General Controls

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.