510(k) K140160
- Device
- RELIEVA SCOUT SINUS DILATION SYSTEM
- Applicant
- ACCLARENT, INC.
- 510(k) number
- K140160
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-02-20
- Date received
- 2014-01-22
- Regulation
- 874.4420
- Classification name
- Instrument, Ent Manual Surgical
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES P GARVEY, II
- Address
- 1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025
FDA Registration Numbers#
- 9614069
- 3013557562
- 3013497507
- 8040233
- 1926681
- 3003836856
- 3006546082
- 8044098
- 1061771
- 3003322138
- 2020550
- 1313525
- 9610612
- 1720747
- 3003418325
- 3012226300
- 9710014
- 3008770252
- 8010523
- 3008843439
- 3017210488
- 3009613036
- 1056350
- 9610905
- 3045853999
- 1932214
- 3007421149
- 3015718821
- 3004450489
- 3008280196
- 3011111237
- 8010298
- 1417592
- 3012507533
- 3004950803
- 3005440795
- 8032044
- 3009307953
- 2135225
- 3023464160
- 9680721
- 3002858762
- 8010591
- 9611274
- 1219795
- 3013247477
- 8010433
- 3027828125
- 3010326886
- 1064858
- 3010155661
- 3012964172
- 8040278
- 3015967359
- 9680515
- 3014201171
- 3030839824
- 9615857
- 3005172759
- 1057946
- 1825146
- 3008729892
- 3016842760
- 8043752
- 3007583964
- 9616024
- 3031531314
- 3011596340
- 3027553379
- 3010269591
- 3042278955
- 1811755
- 3013011598
- 1225984
- 8010155
- 2183744
- 3006345872
- 3036795921
- 1045254
- 9680718
Source Documents#
Other 510(k) Records For Product Code LRC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023-05-25 |
| K212774 | VenSure LightGuide | Intersect Ent. | 2022-02-04 |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020-10-15 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020-08-26 |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017-09-05 |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016-10-24 |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | 2016-06-29 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015-11-20 |
Legacy Summary#
summary
FDA Review#
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