FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stealth AXiS Cranial clinical application
K Number: K253379
·
Decision Mar 26, 2026
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
35
Review Days
177
Basic Information
- Device Name
- Stealth AXiS Cranial clinical application
- K Number
- K253379
- 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 26, 2026
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Medtronic Navigation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253395 | Stealth AXiS ENT clinical application | Mar 16, 2026 | Substantially Equivalent |
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| 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 |