510(k) K222740

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 by Speciality Fibres and Materials, Ltd. — Product Code FRO

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