FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K Number: K243053
·
Decision Jun 20, 2025
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
36
Applicant Total
2
Review Days
266
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
- Navient Image Guided Navigation System (ENT) (955-NC-NC)
- K Number
- K243053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Claronav
- Date Received
- September 27, 2024
- Decision Date
- June 20, 2025
- 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
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
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Claronav
| K Number | Device Name | ||
|---|---|---|---|
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Feb 5, 2025 | Substantially Equivalent |