K222740 is an FDA 510(k) clearance for the Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch. This device is classified as a Dressing, Wound, Drug.
Submitted by Speciality Fibres and Materials, Ltd. (Coventry, GB). The FDA issued a Cleared decision on October 21, 2024, 773 days after receiving the submission on September 9, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K222740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2022 |
| Decision Date | October 21, 2024 |
| Days to Decision | 773 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |