K223249 is an FDA 510(k) clearance for the Pro-Tx Endorectal Balloon (PROT-25). This device is classified as a Prostate Immobilizer Rectal Balloon (Class II - Special Controls, product code PCT).
Submitted by Dxtx Medical, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 10, 2023, 151 days after receiving the submission on September 12, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5720. 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..
| 510(k) Number | K223249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2022 |
| Decision Date | February 10, 2023 |
| Days to Decision | 151 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PCT — Prostate Immobilizer Rectal Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5720 |
| Definition | 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. |