# SpaceOAR Flex™ System (K262151): 510(k) cleared for Boston Scientific Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262151 |
| Device | SpaceOAR Flex™ System |
| Applicant | Boston Scientific Corporation |
| Specialty / panel | Radiology |
| Product code | OVB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-25 |
| Decision date | 2026-09-11 |
| Review time (days) | 78 |
| Third-party review | No |
| Applicant location | Marlborough, MA, US |

## Why this score
- Fast 78-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262151). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.