LiquiBand XL
FDA 510(k) clearance K211878 · decided 2022-05-23
Clearance details
- K-number
- K211878
- Device name
- LiquiBand XL
- Applicant
- Advanced Medical Solutions Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-06-21
- Decision date
- 2022-05-23
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- OMD
- Device class
- 2
- Regulation number
- 878.4011
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S004) | Advanced Medical Solutions Limited | 2023-12-14 |
| LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S001) | Advanced Medical Solutions Limited | 2023-07-28 |
| LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024) | Advanced Medical Solutions Limited | 2023-06-02 |