510(k) DEN130036

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.