510(k) K161697
- Device
- Acclarent NavWire Sinus Navigation Guidewire
- Applicant
- ACCLARENT, INC.
- 510(k) number
- K161697
- Product code
- PGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-10-24
- Date received
- 2016-06-20
- Regulation
- 882.4560
- Classification name
- Ear, Nose, And Throat Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Ear Nose & Throat
- Device class
- 2
- 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
- ANNA HWANG
- Address
- 33 Technology Dr. Irvin CA US 92618 92618
FDA Registration Numbers
- 3010009632
- 3005677016
- 3007361893
- 8010177
- 1221485
- 3008837339
- 9610905
- 3011874573
- 3008203003
- 3005172759
- 3018565642
- 1058084
- 3008087383
- 3009018440
- 1824206
- 3016245399
- 3006697241
- 2183744
- 3010313588
- 9680721
- 8043933
- 2020550
- 3007738736
- 3017060084
- 3009217531
- 3015131155
- 3007421149
- 1811755
- 3003500271
- 3010273872
- 3015967359
- 1723170
- 3010202439
- 9610617
- 3006345872
- 3015462848
- 1928237
- 3014342096
- 3011543740
- 3018094310
- 1225492
- 3003418325
- 3010707607
- 3003678543
- 8040510
- 3005423519
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20705031242903 | ACCLARENT NAVWIRE | ACCLARENT, INC. | 2018-02-28 |
| 20705031237084 | ACCLARENT NAVWIRE | ACCLARENT, INC. | 2017-08-01 |
Legacy Summary
summary
FDA Review
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