SpaceOAR Flex System
FDA 510(k) K262151 · Boston Scientific Corporation
510(k) numberK262151
Submission
- Device name
- SpaceOAR Flex System
- Applicant
- Boston Scientific Corporation
Marlborough, MA, US - Received
- June 25, 2026
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVB – Hydrogel Spacer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5725
- Specialty
- Radiology
The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate…
Other 510(k)s with product code OVB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260119 | SpaceOAR Vue System (SV-2101)OVB · Special | Boston Scientific Corporation | 02/10/2026SE |
| K222972 | BioProtect Balloon Implant SystemOVB · Traditional | Bioprotect, Ltd. | 08/25/2023SE |
| K220641 | Barrigel Injectable GelOVB · Traditional | Palette Life Sciences | 05/26/2022SE |
| K202224 | SpaceOAR SystemOVB · Special | Boston Scientific Corporation | 08/28/2020SE |
| K182971 | SpaceOAR Vue HydrogelOVB · Traditional | Augmenix, Inc. | 07/19/2019SE |
| K181465 | SpaceOAR SystemOVB · Special | Augmenix, Inc. | 06/25/2018SE |
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Questions and answers
When was SpaceOAR Flex System cleared by the FDA?
SpaceOAR Flex System (K262151) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 78 days after the submission was received.
What is the product code of K262151?
The FDA product code is OVB – Hydrogel Spacer, a Class II (moderate risk) device regulated under 21 CFR 892.5725.