Hydrogel Spacer
The Hydrogel Spacer (product code OVB) is a biodegradable implant injected into the perirectal space to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, with the intent of reducing the radiation dose delivered to the anterior rectum. The spacer maintains its position throughout the full course of prostate radiotherapy and is completely absorbed by the body over time. As an FDA Class 2 device under regulation 892.5725, it requires 510(k) premarket clearance and falls within the Radiology specialty. The device is not explicitly flagged as an implant in this record and is not life-sustaining.
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Basic Information
- Product Code
- OVB
- Device Class
- FDA class 2
- Regulation Number
- 892.5725
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260119 | SpaceOAR Vue System (SV-2101) | Feb 10, 2026 | Substantially Equivalent | Boston Scientific Corporation |
| K222972 | BioProtect Balloon Implant System | Aug 25, 2023 | Substantially Equivalent | Bioprotect, Ltd. |
| K220641 | Barrigel Injectable Gel | May 26, 2022 | Substantially Equivalent | Palette Life Sciences |
| K202224 | SpaceOAR System | Aug 28, 2020 | Substantially Equivalent | Boston Scientific Corporation |
| K182971 | SpaceOAR Vue Hydrogel | Jul 19, 2019 | Substantially Equivalent | Augmenix, Inc. |
| K181465 | SpaceOAR System | Jun 25, 2018 | Substantially Equivalent | Augmenix, Inc. |
| DEN140030 | SpaceOAR System | Apr 01, 2015 | Unknown | Augmenix, Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.