FDA.reportPublic FDA data

510(k) K230258

Device
BB 8 Sinus Dilation Kit
Applicant
Excelent, Inc.
510(k) number
K230258
Product code
LRC
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-25
Date received
2023-01-31
Regulation
874.4420
Classification name
Instrument, Ent Manual Surgical
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
Kashif Mazhar
Address
68 Tw Alexander Dr. P.O. Box 13628, Research Triangle Park Durham NC US 27709 27709

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212774VenSure LightGuideIntersect Ent.2022-02-04
K201398SINUSPRIME Dilation SystemStryker Ent2020-10-15
K201115Next Generation Balloon Dilation SystemAcclarent, Inc.2020-08-27
K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH2020-08-26
K181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLC2020-01-03
K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.2019-05-03
K181838Sinusway Dilation System3nt Medical , Ltd.2018-12-20
K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited2017-12-12
K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.2017-09-05
K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.2016-10-24
K160770Vent-Os Sinus Dilation familySinusys Corporation2016-06-29
K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.2016-02-12
K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.2015-12-01
K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.2015-11-20
K152435PassAssist LED Light FiberEntellus Medical, Inc.2015-11-20