510(k) K222740
K222740 is an FDA 510(k) premarket notification submitted by Speciality Fibres and Materials, Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on October 21, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Speciality Fibres and Materials, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2024
- Date Received
- September 9, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type