Device class
Class II
Regulation 892.5725
Total clearances
4
2020-08-28 → 2026-02-10
Definition
What is Hydrogel Spacer
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.
Classification details
Medical specialty
Radiology
Regulation number
892.5725
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 77295 |
CPT
|
— |
Medium
|
3D radiotherapy planning; OVB is hydrogel spacer used as adjunct during prostate radiotherapy planning |
| 77300 |
CPT
|
— |
Medium
|
Basic radiation therapy planning; spacer placement preparation for dose optimization |
Pulse
Most recent 510(k) clearances