K141958 is an FDA 510(k) clearance for the ERB ENDORECTAL BALLOON. This device is classified as a Prostate Immobilizer Rectal Balloon (Class II - Special Controls, product code PCT).
Submitted by Edge Medical, LLC (Lutsen, US). The FDA issued a Cleared decision on November 18, 2014, 123 days after receiving the submission on July 18, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5720. 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..
| 510(k) Number | K141958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2014 |
| Decision Date | November 18, 2014 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PCT — Prostate Immobilizer Rectal Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5720 |
| 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. |