Hydrogel Spacer

OVB is the FDA product code for Hydrogel Spacer, a class II device type, regulated under 21 CFR 892.5725. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2026-02-10, and 2 recalls.