FDA.reportPublic FDA data

510(k) K223167

Device
Spirair Nasal Septal Strap
Applicant
Spirair, Inc.
510(k) number
K223167
Product code
NHB
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-17
Date received
2022-10-07
Regulation
874.3620
Classification name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
James Kintzing
Address
6084 Monterey Hwy., 108 San Jose CA US 95138 95138

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251790SeptAlignSpirair, Inc.2026-01-16
K233569SeptAlignSpirair, Inc.2024-03-22
K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC2022-05-05
K192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent)2019-11-10
K183015PuraSinus3-D Matrix, Inc.2019-04-12
K161191Latera Absorbable Nasal ImplantSpirox, Inc.2016-06-23
K152958INEX Absorbable Nasal ImplantSpirox, Inc.2015-12-04
K132920SPIROX INEX DEVICESpirox, Inc.2014-06-10
K122434MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GELMedtronic Xomed2012-10-31
K092590PDS PLATESETHICON, Inc.2010-02-17
K070715NASOPORE EARPolyganics B.V.,2007-05-07
K070886MEROGEL INJECTABLE BIORESORBABLE STENTMedtronic, Inc.2007-04-26
K012769MACROPORE ENT RECONSTRUCTION FILMMacropore Biosurgery, Inc.2001-10-25
K012409LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTSWalter Lorenz Surgical, Inc.2001-10-18