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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- KERI YEN
- Address
- 1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025
FDA Registration Numbers
- 3006410968
- 3014345718
- 1825146
- 1057358
- 1412854
- 9680515
- 3023464160
- 3035708926
- 1057946
- 3042278955
- 3002807315
- 8040278
- 3012507533
- 3005440795
- 3043013991
- 3042895342
- 9613083
- 2031917
- 1421101
- 8043441
- 2183744
- 3006546082
- 3001614464
- 3002806953
- 1834331
- 3008338766
- 1018470
- 1932180
- 3005575604
- 3025482817
- 3031842642
- 3008280196
- 9615004
- 8032044
- 1720747
- 1313525
- 3011050570
- 3012797688
- 3013557562
- 9610612
- 3010202439
- 3010326886
- 1061771
- 1219653
- 8044098
- 1820334
- 3007225047
- 3008843439
- 3016842760
- 3003678543
- 9610621
- 9613646
- 3004950803
- 8043769
- 3017210488
- 1045254
- 3013528571
- 3012226300
- 1064858
- 8010298
- 3010726901
- 2916714
- 8010510
- 8010177
- 8010617
- 3014498758
- 3013846070
- 3004530184
- 9681147
- 3004450489
- 3008087383
- 3013840437
- 3012422952
- 3006554912
- 8010665
- 3030839824
- 1056350
- 8010591
- 1932214
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20705031230597 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031200552 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031200569 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031200583 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206028 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206035 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206301 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206318 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031227573 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031230573 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031230580 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031200538 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031200545 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031200576 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206011 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206042 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206325 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031206370 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031227580 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
| 20705031230566 | RELIEVA SPIN | ACCLARENT, INC. | 2016-10-01 |
Legacy Summary
summary
FDA Review
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