Prostate Immobilizer Rectal Balloon
FDA product code PCT · Class II (moderate risk) · 21 CFR 892.5720 · Radiology
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.
4510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25)PCT · Abbreviated | Dxtx Medical, Inc. | 02/10/2023SE |
| K180478 | RectalPro 75 Endorectal BalloonPCT · Traditional | Qlrad International , Ltd. | 11/13/2018SE |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301PCT · Traditional | Myriad Medical, LLC | 03/31/2015SE |
| K141958 | Erb Endorectal BalloonPCT · Traditional | Edge Medical, LLC | 11/18/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1391-2025 Class II | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog…Product is mislabeled with the incorrect fill volume. | Angiodynamics, Inc. | 02/04/2025Open, Classified |
| Z-2267-2024 Class II | IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon… | Angiodynamics, Inc. | 05/21/2024Open, Classified |