Prostate Immobilizer Rectal Balloon
Radiology · 21 CFR 892.5720
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Angiodynamics, Inc.Open, ClassifiedMar 18, 2025
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product is mislabeled with the incorrect fill volume.
Z-1391-2025 · View FDA record ↗ - Angiodynamics, Inc.Open, ClassifiedJul 3, 2024
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Z-2267-2024 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Dxtx Medical, Inc.Feb 10, 2023
K223249 · Pro-Tx Endorectal Balloon (PROT-25)
- Qlrad International , Ltd.Nov 13, 2018
K180478 · RectalPro 75 Endorectal Balloon
- Myriad Medical, LLCMar 31, 2015
K150234 · Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
- Edge Medical, LLCNov 18, 2014
K141958 · ERB ENDORECTAL BALLOON
- RadiadyneJan 28, 2014
DEN130036 · PROSTATE IMMOBILIZER RECTAL BALLOON