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510(k) K223249

Pro-Tx Endorectal Balloon (PROT-25) by Dxtx Medical, Inc. — Product Code PCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2023
Date Received
September 12, 2022
Clearance Type
Abbreviated
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 by Dxtx Medical, Inc.

  • K243428 — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Co (July 17, 2025)

Other clearances for product code PCT

  • K180478 — RectalPro 75 Endorectal Balloon (November 13, 2018)
  • K150234 — Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (March 31, 2015)
  • K141958 — ERB ENDORECTAL BALLOON (November 18, 2014)
  • DEN130036 — PROSTATE IMMOBILIZER RECTAL BALLOON (January 28, 2014)