510(k) K182971
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2019
- Date Received
- October 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hydrogel Spacer
- Device Class
- Class II
- Regulation Number
- 892.5725
- Review Panel
- RA
- Submission Type
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.