Prostate Immobilizer Rectal Balloon

PCT is the FDA product code for Prostate Immobilizer Rectal Balloon, a class II device type, regulated under 21 CFR 892.5720. FDA's definition for this code reads: "Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed...". As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2023-02-10, and 2 recalls.