SpaceOAR System— 510(k) K202224
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K202224 for SpaceOAR System, Substantially Equivalent on 2020-08-28. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- 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
- Marlboro, 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 →
Recalls naming K202224
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202224.
Data sourced from openFDA. This site is unofficial and independent of the FDA.