Barrigel Injectable Gel
FDA 510(k) clearance K220641 · decided 2022-05-26
Clearance details
- K-number
- K220641
- Device name
- Barrigel Injectable Gel
- Applicant
- Palette Life Sciences
- Decision
- Substantially Equivalent
- Date received
- 2022-03-04
- Decision date
- 2022-05-26
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- OVB
- Device class
- 2
- Regulation number
- 892.5725
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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| SpaceOAR Vue System (SV-2101) (K260119) | Boston Scientific Corporation | 2026-02-10 |
| BioProtect Balloon Implant™ System (K222972) | Bioprotect, Ltd. | 2023-08-25 |
| SpaceOAR System (K202224) | Boston Scientific Corporation | 2020-08-28 |
| SpaceOAR Vue Hydrogel (K182971) | Augmenix, Inc. | 2019-07-19 |
| SpaceOAR System (K181465) | Augmenix, Inc. | 2018-06-25 |
| SpaceOAR System (DEN140030) | Augmenix, Inc. | 2015-04-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Deflux® Injectable Gel (P000029/S098) | Palette Life Sciences | 2024-05-31 |
| Solesta® Injectable Gel (P100014/S035) | Palette Life Sciences | 2023-12-07 |
| Deflux® Injectable Gel (P000029/S097) | Palette Life Sciences | 2023-12-07 |
| Deflux Injectable Gel (P000029/S096) | Palette Life Sciences | 2023-07-11 |
| Solesta Injectable Gel (P100014/S034) | Palette Life Sciences | 2023-07-11 |
| SOLESTA Injectable Gel (P100014/S032) | Palette Life Sciences | 2022-03-22 |
| DEFLUX Injectable Gel (P000029/S094) | Palette Life Sciences | 2022-03-22 |
| Solesta Injectable Gel (P100014/S033) | Palette Life Sciences | 2022-03-17 |