Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Prostate Immobilizer Rectal Balloon

FDA product code PCT · 2 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.5720
Review panel
RA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2018-11-13 – 2023-02-10

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 healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

↑