DEN140030 is an FDA 510(k) submission for the SpaceOAR System. This device is classified as a Hydrogel Spacer (Class II - Special Controls, product code OVB).
Submitted by Augmenix, Inc. (Waltham, US). The FDA issued a Not Cleared (DENG) decision on April 1, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5725. The Perirectal Spacer Is Intended To Temporarily Position The Anterior Rectal Wall Away From The Prostate During Radiotherapy For Prostate Cancer And In Creating This Space It Is The Intent Of The Perirectal Spacer To Reduce The Radiation Dose Delivered To The Anterior Rectum. The Perirectal Spacer Is Composed Of Biodegradable Material And Maintains Space For The Entire Course Of Prostate Radiotherapy Treatment And Is Completely Absorbed By The Patients Body Over Time..
| 510(k) Number | DEN140030 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 01, 2014 |
| Decision Date | April 01, 2015 |
| Days to Decision | 182 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | OVB - Hydrogel Spacer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5725 |
| Definition | The Perirectal Spacer Is Intended To Temporarily Position The Anterior Rectal Wall Away From The Prostate During Radiotherapy For Prostate Cancer And In Creating This Space It Is The Intent Of The Perirectal Spacer To Reduce The Radiation Dose Delivered To The Anterior Rectum. The Perirectal Spacer Is Composed Of Biodegradable Material And Maintains Space For The Entire Course Of Prostate Radiotherapy Treatment And Is Completely Absorbed By The Patients Body Over Time. |