SpaceOAR Flex System— 510(k) K262151
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K262151 for SpaceOAR Flex System, Substantially Equivalent on 2026-09-11. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
The SpaceOAR Flex System from Boston Scientific is filed under OVB, hydrogel spacers. The code's definition covers a perirectal spacer intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, to reduce the radiation dose to the anterior rectum. The spacer is biodegradable and is absorbed by the body over time.
Class II, 21 CFR 892.5725. The Radiology panel reviewed it as a Traditional 510(k).
Boston Scientific filed from Marlborough, Massachusetts. Review took 78 days (June 25 to September 11, 2026). The record doesn't say what "Flex" refers to.
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
- Traditional
- Location
- Marlborough, 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.