FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TruDi Probe
K Number: K193453
·
Decision Mar 23, 2020
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
34
Applicant Total
11
Review Days
101
Basic Information
- Device Name
- TruDi Probe
- K Number
- K193453
- 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
- December 13, 2019
- Decision Date
- March 23, 2020
- 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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Other Clearances by Acclarent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K201174 | TruDi Curette | Aug 12, 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 |
| K180948 | TruDi NAV Suction Instruments | Jul 20, 2018 | Substantially Equivalent |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Jan 16, 2018 | Substantially Equivalent |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Sep 5, 2017 | Substantially Equivalent |