FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpaceOAR System
K Number: K202224
·
Decision Aug 28, 2020
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
6
Applicant Total
231
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SpaceOAR System
- K Number
- K202224
- 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
- August 7, 2020
- Decision Date
- August 28, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVB), ordered by most recent decision date.
SpaceOAR Vue System (SV-2101)
FDA 510(k)
FDA Class 2
·Radiology
BioProtect Balloon Implant System
FDA 510(k)
FDA Class 2
·Radiology
Barrigel Injectable Gel
FDA 510(k)
FDA Class 2
·Radiology
SpaceOAR Vue Hydrogel
FDA 510(k)
FDA Class 2
·Radiology
SpaceOAR System
FDA 510(k)
FDA Class 2
·Radiology
SpaceOAR System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Boston Scientific Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260428 | RIVOS EUS Access Device (M00553900) | Jun 17, 2026 | Substantially Equivalent |
| K260100 | MOSES Raydar | May 18, 2026 | Substantially Equivalent |
| K260771 | TruSelect 2.6 Microcatheter | May 15, 2026 | Substantially Equivalent |
| K251273 | Asurys Fluid Management System | Mar 27, 2026 | Substantially Equivalent |
| K260479 | TheraSphere 360 Y-90 Management Platform | Mar 13, 2026 | Substantially Equivalent |
| K260119 | SpaceOAR Vue System (SV-2101) | Feb 10, 2026 | Substantially Equivalent |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Oct 30, 2025 | Substantially Equivalent |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | Oct 30, 2025 | Substantially Equivalent |
| K252547 | TheraSphere 360 Y-90 Management Platform | Oct 28, 2025 | Substantially Equivalent |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Sep 26, 2025 | Substantially Equivalent |