OVB

Hydrogel Spacer

Product code

OVB

Device name

Hydrogel Spacer

Device class

Class 2

21 CFR

21 CFR 892.5725

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

7 (all years; only the last 3 years are listed here)

FDA classification 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 patient’s body over time.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-02-10.

1 summaries are archived here for direct download.