Cleared Traditional

K935658 - MEROCEL TURBINATE GLOVE AND SEPTAL SPLINT

K935658 is the FDA 510(k) clearance for MEROCEL TURBINATE GLOVE AND SEPTAL SPLINT by Merocel Corp.. It is a Class 1 Ear, Nose, Throat device (product code LYA) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K935658 · Merocel Corp. · Ear, Nose, Throat device
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Mar 1994
Decision
100d
Days
Class 1
Risk

K935658 is an FDA 510(k) clearance for the MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Merocel Corp. (Mystic, US). The FDA issued a Cleared decision on March 4, 1994 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 874.4780 - 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.

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Submission Details

510(k) Number K935658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1993
Decision Date March 04, 1994
Days to Decision 100 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
11d slower than avg
Panel avg: 89d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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.

Regulatory Peers - LYA Splint, Intranasal Septal

All 10
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K935658.
SPIWay Endonasal Access Guide
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NASAL SEPTAL SPLINT
K952207 · Smith & Nephew Richards, Inc. · Jun 1995
NASAL SEPTAL SPLINT
K921195 · Smith & Nephew Richards, Inc. · Jul 1992
TURBINATE NASAL SPLINT
K921202 · Smith & Nephew Richards, Inc. · Jul 1992