meddevicedb.com FDA Device Reference

PROSTATE IMMOBILIZER RECTAL BALLOON

DEN130036 Class II Direct
Decision Date
2014-01-28
Sponsor / Applicant
Radiadyne

Technical Specification

510(k) Submission ID DEN130036
Product Code PCT
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5720
Decision Date 2014-01-28
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PROSTATE IMMOBILIZER RECTAL BALLOON received FDA 510(k) clearance under submission number DEN130036, sponsored by Radiadyne. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-01-28.

Classification & Regulation

This clearance is catalogued under FDA product code PCT and 21 CFR 892.5720, within the Radiology review panel as a Class II device.