510(k) K181465 ยท OVB Hydrogel Spacer
SpaceOAR System
| Applicant | Augmenix, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jun 25, 2018 |
| Received | Jun 4, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2022 | Boston Scientific Corporation SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiati Open, Classified |
OVB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.