PCT
5 FDA 510(k) clearances · Product code
151 daysmedian time to decision
264 days90th percentile
5clearances measured
FDA profile
- Official device name
- Prostate Immobilizer Rectal Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5720
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Pro-Tx Endorectal Balloon (PROT-25) (K223249) | Dxtx Medical, Inc. | 2023-02-10 |
| RectalPro 75 Endorectal Balloon (K180478) | Qlrad International , Ltd. | 2018-11-13 |
| Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (K150234) | Myriad Medical, LLC | 2015-03-31 |
| ERB ENDORECTAL BALLOON (K141958) | Edge Medical, LLC | 2014-11-18 |
| PROSTATE IMMOBILIZER RECTAL BALLOON (DEN130036) | Radiadyne | 2014-01-28 |
Track PCT automatically
Every clearance here is in the API, with alerts when new ones post.