510(k) K152434
- Device
- XprESS Multi-Sinus Dilation System
- Applicant
- ENTELLUS MEDICAL, INC.
- 510(k) number
- K152434
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-20
- Date received
- 2015-08-27
- 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
- KAREN E. PETERSON
- Address
- 3600 Holly Ln. N., Suite 40 Plymouth MN US 55447 55447
FDA Registration Numbers#
- 3014345718
- 1811755
- 3002858762
- 3010155661
- 3002806740
- 3043013991
- 8043769
- 9610905
- 3015967359
- 3008338766
- 9614069
- 1646831
- 3007689689
- 3005172759
- 1421101
- 8043752
- 3004530184
- 3002807315
- 3013497507
- 9615001
- 3008280196
- 3009092818
- 3016069968
- 8010177
- 3013846070
- 8010269
- 3011111237
- 1057421
- 2434839
- 9680718
- 3042278955
- 1056350
- 3008902714
- 8010168
- 8010510
- 8040278
- 1219653
- 9617426
- 3001084743
- 2025182
- 3003678543
- 3014579188
- 8010298
- 8010547
- 9680721
- 3013840437
- 3016842760
- 3010269591
- 3006546082
- 3004450489
- 1923569
- 3011050570
- 3005423519
- 3005440795
- 3007421149
- 3031240334
- 9615857
- 2020550
- 3005067367
- 3015718821
- 3025961941
- 2183744
- 3003322138
- 9613926
- 2183570
- 1820334
- 3011310592
- 3012422952
- 1421879
- 3004638532
- 2953359
- 1825146
- 3007583964
- 9611112
- 3014201171
- 3010455030
- 3005809810
- 3014342096
- 1061771
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 |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015-11-20 |
Legacy Summary#
summary
FDA Review#
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