DeviceClearance

Product code PCT— Radiology

ERB ENDORECTAL BALLOON

Classification name
Prostate Immobilizer Rectal Balloon
Device class
Class 2
Regulation
21 CFR 892.5720
Advisory panel
Radiology
Total cleared
5
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PCT under 21 CFR 892.5720, via openFDA

Market context for product code PCT

FDA has cleared 5 devices under product code PCT between 2014 and 2023, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCT

Recent clearances under product code PCT

Data sourced from openFDA. This site is unofficial and independent of the FDA.