PCT · Class II · 21 CFR 892.5720

FDA Product Code PCT: Prostate Immobilizer Rectal Balloon

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.

Leading manufacturers include Radiadyne, Edge Medical, LLC and Myriad Medical, LLC.

5
Total
4
Cleared
158d
Avg days
2014
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prostate Immobilizer Rectal Balloon Devices (Product Code PCT)

5 devices
1–5 of 5
Cleared Feb 10, 2023
Pro-Tx Endorectal Balloon (PROT-25)
K223249
Dxtx Medical, Inc.
Radiology · 151d
Cleared Nov 13, 2018
RectalPro 75 Endorectal Balloon
K180478
Qlrad International , Ltd.
Radiology · 264d
Cleared Mar 31, 2015
Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
K150234
Myriad Medical, LLC
Radiology · 57d
Cleared Nov 18, 2014
ERB ENDORECTAL BALLOON
K141958
Edge Medical, LLC
Radiology · 123d
Not Cleared Jan 28, 2014
PROSTATE IMMOBILIZER RECTAL BALLOON
DEN130036
Radiadyne
Radiology · 197d

About Product Code PCT - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code PCT since 2014, with 4 receiving FDA clearance (average review time: 158 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.