Cleared Traditional

K943718 - EPISTAT-II NASAL CATHETER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K943718 · Merocel Corp. · Ear, Nose, Throat device
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Sep 1994
Decision
46d
Days
Class 1
Risk

K943718 is an FDA 510(k) clearance for the EPISTAT-II NASAL CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Merocel Corp. (Mystic, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merocel Corp. devices

Submission Details

510(k) Number K943718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date September 16, 1994
Days to Decision 46 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 89d · This submission: 46d
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.