FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K Number: K200723
·
Decision Jun 26, 2020
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
36
Applicant Total
35
Review Days
99
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Basic Information
- Device Name
- StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
- K Number
- K200723
- 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
- March 19, 2020
- Decision Date
- June 26, 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
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Other Clearances by Medtronic Navigation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | Mar 26, 2026 | Substantially Equivalent |
| K253395 | Stealth AXiS ENT clinical application | Mar 16, 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 |