OVB — Hydrogel Spacer Class II
Classification Details
- Product Code
- OVB
- Device Class
- Class II
- Regulation Number
- 892.5725
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260119 | boston scientific corporation | SpaceOAR Vue System (SV-2101) | February 10, 2026 |
| K222972 | bioprotect | BioProtect Balloon Implant System | August 25, 2023 |
| K220641 | palette life sciences | Barrigel Injectable Gel | May 26, 2022 |
| K202224 | boston scientific corporation | SpaceOAR System | August 28, 2020 |
| K182971 | augmenix | SpaceOAR Vue Hydrogel | July 19, 2019 |
| K181465 | augmenix | SpaceOAR System | June 25, 2018 |
| DEN140030 | augmenix | SpaceOAR System | April 1, 2015 |