510(k) K180478
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2018
- Date Received
- February 22, 2018
- Clearance Type
- Traditional
- 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.