FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TruDi NAV Wire
K Number: K190532
·
Decision May 3, 2019
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
36
Applicant Total
45
Review Days
60
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Basic Information
- Device Name
- TruDi NAV Wire
- K Number
- K190532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acclarent, Inc.
- Date Received
- March 4, 2019
- Decision Date
- May 3, 2019
- Product Code
- PGW
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | FDA class 2 | Neurology |
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|---|---|---|---|
| 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 |
| K183090 | Relieva Tract Balloon Dilation System | Apr 19, 2019 | Substantially Equivalent |
| K180948 | TruDi NAV Suction Instruments | Jul 20, 2018 | Substantially Equivalent |