FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
K Number: K250752
·
Decision Apr 9, 2025
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
90
Applicant Total
13
Review Days
28
Basic Information
- Device Name
- AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K Number
- K250752
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- March 12, 2025
- Decision Date
- April 9, 2025
- Product Code
- GWG
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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