SpaceOAR System
FDA 510(k) clearance K181465 · decided 2018-06-25
Clearance details
- K-number
- K181465
- Device name
- SpaceOAR System
- Applicant
- Augmenix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-04
- Decision date
- 2018-06-25
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- OVB
- Device class
- 2
- Regulation number
- 892.5725
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SpaceOAR Vue System (SV-2101) (K260119) | Boston Scientific Corporation | 2026-02-10 |
| BioProtect Balloon Implantâ„¢ System (K222972) | Bioprotect, Ltd. | 2023-08-25 |
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |
| SpaceOAR System (K202224) | Boston Scientific Corporation | 2020-08-28 |
| SpaceOAR Vue Hydrogel (K182971) | Augmenix, Inc. | 2019-07-19 |
| SpaceOAR System (DEN140030) | Augmenix, Inc. | 2015-04-01 |
Recalls involving this device
No recalls on record reference this clearance.