510(k) K182971 ยท OVB Hydrogel Spacer
SpaceOAR Vue Hydrogel
| Applicant | Augmenix, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jul 19, 2019 |
| Received | Oct 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182971
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2022 | Boston Scientific Corporation SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose deliver Open, Classified |
OVB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.