510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222740Substantially Equivalent

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

Speciality Fibres and Materials Limited, Coventry, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222740 is the FDA 510(k) clearance record for 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, cleared for Speciality Fibres and Materials, Ltd. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 3 510(k) clearances for Speciality Fibres and Materials, Ltd., from to . As of , FDA records show no recalls naming K222740.

Clearance record

Decision date
Received
(773 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Speciality Fibres and Materials, Ltd. Galaxy House Binley Industrial Estate,, Coventry, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260