Cleared Traditional

K130354 - MEDIENT MIDDLE TURBINATE IMPLANT

Also marketed or referenced as:
(SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

K130354 is an FDA 510(k) clearance for MEDIENT MIDDLE TURBINATE IMPLANT, manufactured by Entrigue Surgical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K130354 · Entrigue Surgical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
106d
Days
Class 1
Risk

K130354 is an FDA 510(k) clearance for the MEDIENT MIDDLE TURBINATE IMPLANT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Entrigue Surgical, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 29, 2013 after a review of 106 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 Entrigue Surgical, Inc. devices

FDA 510(k) Submission Details - K130354

510(k) Number K130354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2013
Decision Date May 29, 2013
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 90d · This submission: 106d
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.

Clinical Evidence

ClinicalTrials.gov
NCT01733667 Completed Interventional Industry-sponsored

A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery

60
Patients (actual)
5
Sites
Prevention
Purpose
Open label
Masking
Condition studied Synechia
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor ENTrigue Surgical, Inc. (industry)
Started 2011-12-01 → Primary completion 2012-12-01 → Completed 2013-02-01
Primary outcome
Miller synechia score at 8 weeks
Secondary outcome
Miller Score at 4 & 8 weeks
Study completed - no results published. This trial concluded in 2013 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LYA Splint, Intranasal Septal

All 37
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K130354.
NASOPORE-FD
K141423 · Polyganics B.V., · Aug 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · ArthroCare Corporation · Jun 2014
SPIWAY ENDONASAL ACCESS GUIDE
K132721 · Spiway, LLC · Jan 2014
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
K122494 · Hemostasis, LLC · Mar 2013
NASAL/EPISTAXIS PACK
K113585 · Cogent Therapeutics, LLC · Apr 2012
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
K092401 · Sinexus, Inc. · Nov 2009