SpaceOAR Vue System (SV-2101)— 510(k) K260119
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K260119 for SpaceOAR Vue System (SV-2101), Substantially Equivalent on 2026-02-10. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's SpaceOAR Vue System (SV-2101) is filed under product code OVB, hydrogel spacer. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.5725. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
The record lists the applicant location as Marborough, Massachusetts. The decision came 27 calendar days after FDA received it (January 14 to February 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code OVB
- Device class
- Class 2
- Regulation
- 21 CFR 892.5725
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marborough, MA, US
Recent devices under product code OVB
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code OVB
product code OVB- Death
- 7
- Injury
- 658
- Malfunction
- 1,206
- Total
- 1,871
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.