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510(k) K150234

Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 by Myriad Medical, LLC — Product Code PCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2015
Date Received
February 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prostate Immobilizer Rectal Balloon
Device Class
Class II
Regulation Number
892.5720
Review Panel
RA
Submission Type

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.

Other clearances for product code PCT

  • K223249 — Pro-Tx Endorectal Balloon (PROT-25) (February 10, 2023)
  • K180478 — RectalPro 75 Endorectal Balloon (November 13, 2018)
  • K141958 — ERB ENDORECTAL BALLOON (November 18, 2014)
  • DEN130036 — PROSTATE IMMOBILIZER RECTAL BALLOON (January 28, 2014)