Prostate Immobilizer Rectal Balloon

PCT · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5720

Classification

FDA Product Code: PCT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.5720
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 7

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown