Antimicrobial Silicone PHMB Foam Wound Dressing
FDA 510(k) clearance K223310 · decided 2023-04-05
Clearance details
- K-number
- K223310
- Device name
- Antimicrobial Silicone PHMB Foam Wound Dressing
- Applicant
- Advanced Medical Solutions Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-10-28
- Decision date
- 2023-04-05
- Days to decision
- 159 days
- Clearance type
- Special
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Winsford, GB
- Third-party review
- No
- Expedited review
- No
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| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
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 |