510(k) K111875
- Device
- RELIEVA SPIN SINUS DILATION SYSTEM
- Applicant
- ACCLARENT, INC.
- 510(k) number
- K111875
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-10-11
- Date received
- 2011-07-01
- 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
- KERI YEN
- Address
- 1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025
FDA Registration Numbers#
- 3008280196
- 1123010
- 3004638532
- 3014334038
- 2529846
- 3005575604
- 3008087383
- 3003761012
- 3006154292
- 9616024
- 1923569
- 3008902714
- 3003644849
- 3004608878
- 1057946
- 8010591
- 8043441
- 8010523
- 3005440795
- 1057421
- 1926681
- 2183319
- 2434839
- 8043769
- 3012797688
- 8043752
- 3013497507
- 3031842642
- 3035708926
- 3016069968
- 3004001706
- 3005067367
- 3011137372
- 3009307953
- 3011310592
- 3027553379
- 3042278955
- 8010257
- 3004450489
- 1932214
- 3005216725
- 2916714
- 3031531314
- 3003322138
- 3002834291
- 3011050570
- 3012267976
- 3025961941
- 9610773
- 3017210488
- 3011237770
- 3023657851
- 2025182
- 9611112
- 3013011598
- 1932180
- 3003435550
- 1219653
- 3010041511
- 3014345718
- 3014579188
- 3012964172
- 8010665
- 1811755
- 3030839824
- 3013846070
- 8040233
- 3007367732
- 1018470
- 8010617
- 3007137643
- 3012226300
- 3006405073
- 9613646
- 1720747
- 1048735
- 3012422952
- 3005900820
- 3002806953
- 3002858762
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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