510(k) K202224
K202224 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "SpaceOAR System". The FDA issued a decision of Substantially Equivalent on August 28, 2020. The device falls under product code OVB (Hydrogel Spacer), a Class II device regulated under 21 CFR 892.5725. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2020
- Date Received
- August 7, 2020
- Clearance Type
- Special
- 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.