FDA Registration
Active
🇺🇸 United States
ACCLARENT, INC.
Reg #: 3005172759
·
FEI: 3005172759
·
Expires 2026
Products
11
Proprietary Names
29
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- ACCLARENT, INC.
- Registration Number
- 3005172759
- FEI Number
- 3005172759
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7585 Irvine Center Dr
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190532
Owner / Operator
- Firm Name
- ACCLARENT, INC.
- Operator Number
- 9068915
- Address
- 7585 Irvine Center Drive, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2019-05-08 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2020-08-28 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2020-08-28 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2012-01-18 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2022-08-15 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2012-01-13 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2012-01-13 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2009-07-29 |
| Punch, Ethmoid | KAX | Class 1 | Ear, Nose, Throat | No | 2015-09-16 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2013-10-30 |
| Balloon, Nasal Airway | QGK | Class 1 | Ear, Nose, Throat | No | 2019-04-25 |
Proprietary Names
TruDi NAVWIRE
TruDi Navigation System
Acclarent ENT Navigation System
ACCLARENT PIVOT Balloon Dilation Systems
Light Guide Cable Adapters
Relieva Luma Light Guide Cable 2
TruDi Shaver Blade
Relieva Luma Sentry Sinus Illumination System
Relieva SpinPlus Balloon Sinuplasty System
Acclarent Inflation Device
Cyclops Multi-Angle Endoscope
TruDi NAV Cable
TruDi NAV Suction
Relieva Spin Balloon Sinuplasty System
ACCLARENT SE Inflation Device
Relieva Ultirra Sinus Balloon Catheter
Relieva Flex Guide Catheter
Relieva Sidekick LP
Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter
Acclarent AERA Eustachian Tube Balloon Dilation System
Acclarent Navwire Sinus Navigation Guidewire
Scout® Multi-Sinus Dilation System
TruDi® Curette
TruDi Probe
Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System
Inspira Air Balloon Dilation System
Relieva Circa Ethmoid Punch
Relieva Vortex 2
Relieva Tract Balloon Dilation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility