FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TruDi Curette
K Number: K201174
·
Decision Aug 12, 2020
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
36
Applicant Total
45
Review Days
103
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
- TruDi Curette
- K Number
- K201174
- 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
- May 1, 2020
- Decision Date
- August 12, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGW), ordered by most recent decision date.
Cube 4D Navigation System, VirtuEye Pro
FDA 510(k)
FDA Class 2
·Neurology
Stealth AXiS ENT clinical application
FDA 510(k)
FDA Class 2
·Neurology
Navient Image Guided Navigation System (ENT) (955-NC-NC)
FDA 510(k)
FDA Class 2
·Neurology
TruDi® Navigation System V3 (FG-2000-00)
FDA 510(k)
FDA Class 2
·Neurology
ENT EM
FDA 510(k)
FDA Class 2
·Neurology
TruDi Shaver Blade
FDA 510(k)
FDA Class 2
·Neurology
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 |
| 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 |
| K180948 | TruDi NAV Suction Instruments | Jul 20, 2018 | Substantially Equivalent |