510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN130036Unknown

Prostate Immobilizer Rectal Balloon

Radiadyne, Washington DC / Direct, Unknown
FDA source (opens on fda.gov)

DEN130036 is the FDA 510(k) clearance record for PROSTATE IMMOBILIZER RECTAL BALLOON, a class II device, cleared for Radiadyne on under FDA product code PCT (Prostate Immobilizer Rectal Balloon). FDA's definition for product code PCT 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)...". FDA records list 5 510(k) clearances for Radiadyne, from to . As of , FDA records show no recalls naming DEN130036.

Clearance record

Decision date
Received
(197 days to decision)
Product code
PCT Prostate Immobilizer Rectal Balloon
Regulation
21 CFR 892.5720
Device class
Class II
Review panel
Radiology
Applicant
Radiadyne 901 New York Ave., NW, Washington DC
Third party review
No

Clearances, product code PCT

Trailing 12 months

FDA records hold no clearances under product code PCT in the trailing twelve months.

FDA records show no clearances under product code PCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260