FRO — Dressing, Wound, Drug Class U
FDA Device Classification
Classification Details
- Product Code
- FRO
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251999 | solventum germany | Promogran Prisma Collagen Matrix with ORC and Silver | March 13, 2026 |
| K252028 | huizhou foryou medical co | LUOFUCON® Antimicrobial Wound Gel | March 11, 2026 |
| K251582 | beijing kreate medical co | Redermax Antibacterial Wound Matrix | February 2, 2026 |
| K252568 | silk holdings | New Day Skin Spray | January 23, 2026 |
| K250890 | sioxmed | SBC1 Cream | January 12, 2026 |
| K252759 | kane biotech | revyve® Antimicrobial Skin and Wound Cleanser | January 8, 2026 |
| K251757 | innovacyn | Puracyn® Plus Antimicrobial Irrigation Solution | January 5, 2026 |
| K252167 | qingdao bright moon biomedical materials co | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber | December 19, 2025 |
| K250642 | huizhou foryou medical devices co | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | November 19, 2025 |
| K250115 | rapid nexus nanotech wound solutions | Hemastyl() Wound Dressing | October 14, 2025 |
| K251866 | solventum us | Tegaderm Post-Op Transparent Antimicrobial Dressing | October 10, 2025 |
| K243166 | infection elimination solutions | Dermalage | August 27, 2025 |
| K243415 | p.g.f. industry solutions | Granudacyn® Wound Irrigation Solution | July 22, 2025 |
| K251093 | oneness biotech co | Bonvadis® | June 9, 2025 |
| K243457 | seriously clean | Nixall Antimicrobial Solutions Skin & Wound Hydrogel | May 2, 2025 |
| K243875 | spectrum antimicrobials | Spectricept Skin and Wound Cleanser | April 21, 2025 |
| K242406 | sioxmed | SiOxC Cream | March 13, 2025 |
| K243001 | laboratorios biogalenic s.a. de c.v | Sterile Water USP and Sterile 0.9% Normal Saline USP | March 6, 2025 |
| K240809 | huizhou foryou medical devices co | LUOFUCON® Silver Collagen Dressing | December 16, 2024 |
| K242758 | hartmann usa | Atrauman® Ag | December 9, 2024 |