Cleared Traditional

K130354 - MEDIENT MIDDLE TURBINATE IMPLANT (FDA 510(k) Clearance)

Also includes:
(SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

Class I Ear, Nose, Throat device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 89d · This submission: 106d
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 45
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K130354.
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