Medient Middle Turbinate Implant; (Single PACK-1 Pair, Four PACK-4 Pair)

FDA 510(k) K130354 · Entrigue Surgical, Inc.

Substantially Equivalent

510(k) numberK130354

Submission

Device name
Medient Middle Turbinate Implant; (Single PACK-1 Pair, Four PACK-4 Pair)
Applicant
Entrigue Surgical, Inc.
San Antonio, TX, US
Received
February 12, 2013
Decision date
May 29, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LYA – Splint, Intranasal Septal
Device class
Class I (low risk)
Regulation
21 CFR 874.4780
Specialty
Ear, Nose, Throat

Other 510(k)s with product code LYA

510(k)DeviceApplicantDecision
K243655TurbAlignLYA · Traditional Spirair, Inc.07/11/2025SE
K230142Epi-Stop Nasal Gel/epistaxis packLYA · Traditional Biomed Ent, Inc.03/22/2023SE
K213153SPIWay Endonasal Access GuideLYA · Special Spiway, LLC10/27/2021SE
K202623Novapak Nasal Sinus Packing and StentLYA · Traditional Medtronic Xomed12/08/2020SE
K181696ChitoZolveLYA · Traditional Gyrus Acmi, Inc.11/30/2018SE
K180141SPIWay Endonasal Access GuideLYA · Special Spiway, LLC02/16/2018SE
K170913Composite Removable Sinus Stent SystemLYA · Traditional Sts Medical12/15/2017SE
K172179Chitogel Endoscopic Sinus Surgery KitLYA · Traditional Chitogel, Ltd.10/17/2017SE
K153686SPIWay Endonasal Access GuideLYA · Special Spiway, LLC01/28/2016SE
K141816HemoporeLYA · Traditional Polyganics B.V.,10/23/2014SE

More from Polyganics B.V.,

510(k)DeviceDecision
K121351Sinus Dilation SystemLRC · Traditional 08/29/2012SE
K082750Entact Septal Stapler, Model 610-00100OLL · Traditional 01/06/2009SE
K072470Bioelast 5-0 Suture, Model 500100NWJ · Traditional 11/16/2007SE

Questions and answers

When was Medient Middle Turbinate Implant; (Single PACK-1 Pair, Four PACK-4 Pair) cleared by the FDA?

Medient Middle Turbinate Implant; (Single PACK-1 Pair, Four PACK-4 Pair) (K130354) received a 510(k) decision of Substantially Equivalent on May 29, 2013, 106 days after the submission was received.

What is the product code of K130354?

The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.