FDA.reportPublic FDA data

510(k) K243655

Device
TurbAlign
Applicant
Spirair, Inc.
510(k) number
K243655
Product code
LYA
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-11
Date received
2024-11-26
Regulation
874.4780
Classification name
Splint, Intranasal Septal
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tracey Henry
Address
415 Grand Ave. Suite 201 South San Francisco Ca US 94080 94080

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.2023-03-22
K213153SPIWay Endonasal Access GuideSpiway, LLC2021-10-27
K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed2020-12-08
K181696ChitoZolveGyrus Acmi, Inc.2018-11-30
K180141SPIWay Endonasal Access GuideSpiway, LLC2018-02-16
K170913Composite Removable Sinus Stent SystemSts Medical2017-12-15
K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.2017-10-17
K153686SPIWay Endonasal Access GuideSpiway, LLC2016-01-28
K141816HEMOPOREPolyganics B.V.,2014-10-23
K141704NOVASHIELD INJECTABLE NASAL PACKING AND STENTMedtronic, Inc.2014-10-06
K141423NASOPORE-FDPolyganics B.V.,2014-08-07
K140992ARTHROCARE NASASTENT CMC NASAL DRESSINGArthroCare Corporation2014-06-16
K132721SPIWAY ENDONASAL ACCESS GUIDESpiway, LLC2014-01-29
K130354MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)Entrigue Surgical, Inc.2013-05-29
K122494POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINTHemostasis, LLC2013-03-27