K222972 is an FDA 510(k) clearance for the BioProtect Balloon Implant™ System. This device is classified as a Hydrogel Spacer (Class II - Special Controls, product code OVB).
Submitted by Bioprotect, Ltd. (Tzur Yigal, IL). The FDA issued a Cleared decision on August 25, 2023, 332 days after receiving the submission on September 27, 2022.
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 | K222972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2022 |
| Decision Date | August 25, 2023 |
| Days to Decision | 332 days |
| Submission Type | Traditional |
| 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. |