Cleared Traditional

K092401 - SINEXUS SINUS STENT GEN 2

K092401 is an FDA 510(k) clearance for SINEXUS SINUS STENT GEN 2, manufactured by Sinexus, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K092401 · Sinexus, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
103d
Days
Class 1
Risk

K092401 is an FDA 510(k) clearance for the SINEXUS SINUS STENT GEN 2, MODEL 1999-25. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Sinexus, Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 17, 2009 after a review of 103 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.

View all Sinexus, Inc. devices

FDA 510(k) Submission Details - K092401

510(k) Number K092401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2009
Decision Date November 17, 2009
Days to Decision 103 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
14d slower than avg
Panel avg: 89d · This submission: 103d
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 19
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K092401.
SPIWay Endonasal Access Guide
K180141 · Spiway, LLC · Feb 2018
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · Medtronic, Inc. · Oct 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · ArthroCare Corporation · Jun 2014
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004
SEPRAGEL SINUS
K012532 · Genzyme Corp. · Oct 2001
LACTOSORB ETHMOID STENT
K002131 · Walter Lorenz Surgical, Inc. · Apr 2001