LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
FDA premarket approval P220024 · decided 2023-06-02
Approval details
- PMA number
- P220024
- Trade name
- LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
- Generic name
- Tissue adhesive internal use
- Applicant
- Advanced Medical Solutions Limited
- Date received
- 2022-10-27
- Decision date
- 2023-06-02
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- PLJ
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plymouth
- Statement
- Approval for The LIQUIFIX FIX8 Hernia Mesh Fixation device is intended for use in laparoscopic surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall and the approximation of the peritoneum.The LIQUIFIX Precision Open Hernia Mesh Fixation device is intended for use in open surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyeste
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Antimicrobial Silicone PHMB Foam Wound Dressing (K223310) | Advanced Medical Solutions Limited | 2023-04-05 |
| LiquiBand XL (K211878) | Advanced Medical Solutions Limited | 2022-05-23 |
| LiquiBand Plus (K183570) | Advanced Medical Solutions Limited | 2020-03-09 |
| SILVER ANTIMICROBIAL WOUND GEL (K110458) | Advanced Medical Solutions Limited | 2011-03-14 |
| SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (K091013) | Advanced Medical Solutions Limited | 2009-07-30 |
| SILVER ALGINATE 11 WOUND DRESSING (K090453) | Advanced Medical Solutions Limited | 2009-02-26 |
| SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (K080503) | Advanced Medical Solutions Limited | 2008-11-12 |
| NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363) | Advanced Medical Solutions Limited | 2008-09-24 |