FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Relieva SpinPlus Nav Balloon Sinuplasty System
K Number: K171687
·
Decision Sep 5, 2017
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
45
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Relieva SpinPlus Nav Balloon Sinuplasty System
- K Number
- K171687
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acclarent, Inc.
- Date Received
- June 7, 2017
- Decision Date
- September 5, 2017
- Product Code
- LRC
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRC), ordered by most recent decision date.
BB 8 Sinus Dilation Kit
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VenSure LightGuide
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SINUSPRIME Dilation System
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Next Generation Balloon Dilation System
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VenSure Balloon Device, VenSure Nav Balloon Device
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Dillard Nasal Balloon Catheter
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Acclarent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Feb 19, 2026 | Substantially Equivalent |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Dec 13, 2023 | Substantially Equivalent |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Jul 21, 2023 | Substantially Equivalent |
| K221037 | TruDi Shaver Blade | Jul 20, 2022 | Substantially Equivalent |
| K201115 | Next Generation Balloon Dilation System | Aug 27, 2020 | Substantially Equivalent |
| K201174 | TruDi Curette | Aug 12, 2020 | Substantially Equivalent |
| K193453 | TruDi Probe | Mar 23, 2020 | Substantially Equivalent |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | May 3, 2019 | Substantially Equivalent |
| K190532 | TruDi NAV Wire | May 3, 2019 | Substantially Equivalent |
| K183090 | Relieva Tract Balloon Dilation System | Apr 19, 2019 | Substantially Equivalent |