FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpaceOAR Vue System (SV-2101)
K Number: K260119
·
Decision Feb 10, 2026
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
6
Applicant Total
231
Review Days
27
Basic Information
- Device Name
- SpaceOAR Vue System (SV-2101)
- K Number
- K260119
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5725
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- January 14, 2026
- Decision Date
- February 10, 2026
- Product Code
- OVB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| OVB | Hydrogel Spacer | FDA class 2 | Radiology |
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