FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stealth AXiS ENT clinical application
K Number: K253395
·
Decision Mar 16, 2026
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
36
Applicant Total
35
Review Days
167
Basic Information
- Device Name
- Stealth AXiS ENT clinical application
- K Number
- K253395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Navigation, Inc.
- Date Received
- September 30, 2025
- Decision Date
- March 16, 2026
- 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
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
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Medtronic Navigation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | Mar 26, 2026 | Substantially Equivalent |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Mar 13, 2026 | Substantially Equivalent |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Feb 12, 2026 | Substantially Equivalent |
| K251282 | StealthStation S8 Spine Software | Oct 17, 2025 | Substantially Equivalent |
| K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | Jun 5, 2025 | Substantially Equivalent |
| K240465 | O-arm O2 Imaging System | Jun 21, 2024 | Substantially Equivalent |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Oct 19, 2023 | Substantially Equivalent |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Jun 10, 2022 | Substantially Equivalent |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Jan 7, 2022 | Substantially Equivalent |
| K203639 | StealthStation Cranial Software v1.3.2 | Jan 13, 2021 | Substantially Equivalent |