510(k) DEN130036
DEN130036 is an FDA 510(k) premarket notification submitted by Radiadyne for the device "PROSTATE IMMOBILIZER RECTAL BALLOON". The FDA issued a decision of De Novo Granted on January 28, 2014. The device falls under product code PCT (Prostate Immobilizer Rectal Balloon), a Class II device regulated under 21 CFR 892.5720. Radiadyne has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 28, 2014
- Date Received
- July 15, 2013
- Clearance Type
- Direct
- 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.