Hydrogel Spacer
FDA product code OVB · Class II (moderate risk) · 21 CFR 892.5725 · 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 radiotherapy treatment and is completely absorbed by the patients body over time.
7510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | Boston Scientific Corporation | 09/11/2026SE |
| 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 |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1003-2022 Class II | SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior…Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements.… | Boston Scientific Corporation | 02/24/2022Open, Classified |
| Z-1002-2022 Class II | SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily…Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements.… | Boston Scientific Corporation | 02/24/2022Open, Classified |