OVB
7 FDA 510(k) clearances · Product code
83 daysmedian time to decision
332 days90th percentile
7clearances measured
FDA profile
- Official device name
- Hydrogel Spacer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5725
- Medical specialty
- Radiology
- FDA definition
- 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.
- Adverse events (MAUDE)
- 2021: 272 · 2022: 387 · 2023: 327 · 2024: 329 · 2025: 340 · 2026: 205
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SpaceOAR Vue System (SV-2101) (K260119) | Boston Scientific Corporation | 2026-02-10 |
| BioProtect Balloon Implant™ System (K222972) | Bioprotect, Ltd. | 2023-08-25 |
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |
| SpaceOAR System (K202224) | Boston Scientific Corporation | 2020-08-28 |
| SpaceOAR Vue Hydrogel (K182971) | Augmenix, Inc. | 2019-07-19 |
| SpaceOAR System (K181465) | Augmenix, Inc. | 2018-06-25 |
| SpaceOAR System (DEN140030) | Augmenix, Inc. | 2015-04-01 |
Track OVB automatically
Every clearance here is in the API, with alerts when new ones post.