Cleared Traditional

K933152 - MEROCEL MEROSPLINT

K933152 is an FDA 510(k) clearance for MEROCEL MEROSPLINT, manufactured by Merocel Corp.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K933152 · Merocel Corp. · Ear, Nose, Throat device
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Aug 1993
Decision
49d
Days
Class 1
Risk

K933152 is an FDA 510(k) clearance for the MEROCEL MEROSPLINT. 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 August 17, 1993 after a review of 49 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K933152

510(k) Number K933152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date August 17, 1993
Days to Decision 49 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
41d faster than avg
Panel avg: 90d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

LYA Device Classification - Class 1, General Controls

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 38
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K933152.
NASAL SEPTAL SPLINT
K952207 · Smith & Nephew Richards, Inc. · Jun 1995
NASAL SPLINT
K945555 · Ultracell Medical Technologies, Inc. · Jan 1995
BIVONA NASAL TURBINATE STENT
K935053 · Bivona Medical Technologies · Jul 1994
NASAL SEPTAL SPLINT
K921195 · Smith & Nephew Richards, Inc. · Jul 1992
TURBINATE NASAL SPLINT
K921202 · Smith & Nephew Richards, Inc. · Jul 1992
FLORET NASAL TAMPON
K830263 · Ritmed, Inc. · Mar 1983