PCT — Prostate Immobilizer Rectal Balloon Class II
FDA product code PCT covers "Prostate Immobilizer Rectal Balloon", a Class II medical device regulated under 21 CFR 892.5720. Submissions are reviewed by the Radiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PCT
- Device Class
- Class II
- Regulation Number
- 892.5720
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223249 | dxtx medical | Pro-Tx Endorectal Balloon (PROT-25) | February 10, 2023 |
| K180478 | qlrad international | RectalPro 75 Endorectal Balloon | November 13, 2018 |
| K150234 | myriad medical | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | March 31, 2015 |
| K141958 | edge medical | ERB ENDORECTAL BALLOON | November 18, 2014 |
| DEN130036 | radiadyne | PROSTATE IMMOBILIZER RECTAL BALLOON | January 28, 2014 |