Prostate Immobilizer Rectal Balloon
The Prostate Immobilizer Rectal Balloon is a radiology device intended for the temporary positioning of the rectal wall and adjacent structures in male patients, typically used during radiation therapy planning or delivery to reduce rectal dose and improve reproducibility of prostate positioning. It falls under the Radiology medical specialty and is classified as a Class 2 device under regulation 892.5720, requiring 510(k) premarket notification. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCT
- Device Class
- FDA class 2
- Regulation Number
- 892.5720
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Feb 10, 2023 | Substantially Equivalent | Dxtx Medical, Inc. |
| K180478 | RectalPro 75 Endorectal Balloon | Nov 13, 2018 | Substantially Equivalent | Qlrad International , Ltd. |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Mar 31, 2015 | Substantially Equivalent | Myriad Medical, LLC |
| K141958 | ERB ENDORECTAL BALLOON | Nov 18, 2014 | Substantially Equivalent | Edge Medical, LLC |
| DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON | Jan 28, 2014 | Unknown | Radiadyne |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.