Hydrogel Spacer
Regulation 892.5725
2510(k)s in 12 months (8 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OVB
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 3 | 2 |
| Augmenix, Inc. | 3 | 0 |
| Bioprotect, Ltd. | 1 | 0 |
| Palette Life Sciences | 1 | 0 |
| 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 | K182971 |
| 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 | K181465 K202224 |
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