FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RELIEVA SCOUT SINUS DILATION SYSTEM
K Number: K140160
·
Decision Feb 20, 2014
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
45
Review Days
29
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Basic Information
- Device Name
- RELIEVA SCOUT SINUS DILATION SYSTEM
- K Number
- K140160
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acclarent, Inc.
- Date Received
- January 22, 2014
- Decision Date
- February 20, 2014
- 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 |
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Other Clearances by Acclarent, Inc.
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|---|---|---|---|
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| 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 |