What is FDA product code PCT?

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.

Radiology › TherapeuticProstate Immobilizer Rectal Balloon

Prostate Caddy Rectal Balloon

Name: Prostate Caddy Rectal Balloon
Brand: Prostate Caddy Rectal Balloon

Prostate Immobilization device. Rectal Balloon and inflation syringe, single use, non-sterile. Kit Box of 25.

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PCT
Manufacturer	City	Province	Registered as	Device types
Koo (Shanghai) Industries Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	9

Record

Regulatory record for Prostate Caddy Rectal Balloon
Listed by	Myriad Medical LLC, United States
FDA product code	PCT
Device type	Prostate Immobilizer Rectal Balloon
Device class	Class 2
Regulation	21 CFR 892.5720
Establishment	Specification developer, Manufacturer
Record published	2020-09-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Prostate Caddy Rectal Balloon
Catalogue number	Per pack	Status
9901	25	In distribution
3309	25	In distribution
3301	50	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ImmobiLoc	Radiadyne, L.L.C.	5
IsoLoc	Radiadyne, L.L.C.	3
Qlrad	Qlrad	3
Bionix Radiation Therapy	Bionix Radiation Therapy, LLC	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K150234	2015-03-31

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.