K181465 is an FDA 510(k) clearance for the SpaceOAR System. This device is classified as a Hydrogel Spacer (Class II - Special Controls, product code OVB).
Submitted by Augmenix, Inc. (Bedford, US). The FDA issued a Cleared decision on June 25, 2018, 21 days after receiving the submission on June 4, 2018.
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 | K181465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2018 |
| Decision Date | June 25, 2018 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| 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. |