510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972458Substantially Equivalent

Lyocell Wound Dressing/surgical Sponge

Courtaulds Fibers, Inc., Axis AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972458 is the FDA 510(k) clearance record for LYOCELL WOUND DRESSING/SURGICAL SPONGE, cleared for Courtaulds Fibers, Inc. on under FDA product code MGP (Dressing, Wound And Burn, Occlusive). FDA records list 3 510(k) clearances for Courtaulds Fibers, Inc., from to . As of , FDA records show no recalls naming K972458.

Clearance record

Decision date
Received
(80 days to decision)
Product code
MGP Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Review panel
Unknown
Applicant
Courtaulds Fibers, Inc. Hwy. 43, N., Axis AL
510(k) summary
Statement
Third party review
No

Clearances, product code MGP

Trailing 12 months

FDA records hold no clearances under product code MGP in the trailing twelve months.

FDA records show no clearances under product code MGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260