510(k) K141958
K141958 is an FDA 510(k) premarket notification submitted by Edge Medical, LLC for the device "ERB ENDORECTAL BALLOON". The FDA issued a decision of Substantially Equivalent on November 18, 2014. The device falls under product code PCT (Prostate Immobilizer Rectal Balloon), a Class II device regulated under 21 CFR 892.5720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2014
- Date Received
- July 18, 2014
- 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.