Cleared Traditional

ULTRACELL PACKING WITH SLEEVE (K973085) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K973085 · Ultracell Medical Technologies, Inc. · Ear, Nose, Throat device
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Nov 1997
Decision
92d
Days
Class 1
Risk

K973085 is an FDA 510(k) clearance for the ULTRACELL PACKING WITH SLEEVE. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on November 18, 1997 after a review of 92 days - within the typical 510(k) review window.

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 Ultracell Medical Technologies, Inc. devices

Submission Details

510(k) Number K973085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date November 18, 1997
Days to Decision 92 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
3d slower than avg
Panel avg: 89d · This submission: 92d
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.