FDA Product Code
FDA Product Code OVB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5725
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262151 | SpaceOAR Flex System | Boston Scientific Corporation | 2026-09-11 | Traditional | PDF ↗ |
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | 2026-02-10 | Special | PDF ↗ |
| K222972 | BioProtect Balloon Implant System | Bioprotect, Ltd. | 2023-08-25 | Traditional | PDF ↗ |
| K220641 | Barrigel Injectable Gel | Palette Life Sciences | 2022-05-26 | Traditional | PDF ↗ |
| K202224 | SpaceOAR System | Boston Scientific Corporation | 2020-08-28 | Special | PDF ↗ |
| K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | 2019-07-19 | Traditional | PDF ↗ |
| K181465 | SpaceOAR System | Augmenix, Inc. | 2018-06-25 | Special | PDF ↗ |
| DEN140030 | SpaceOAR System | Augmenix, Inc. | 2015-04-01 | Direct | — |
Product code OVB · Class II · Radiology. Data: openFDA.