510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080383Substantially Equivalent

Aquacel Hydrofiber Wound Dressing and Ag Hydrofiber Dressing

Convatec, A Division of E.R. Squibb & Sons, Skillman NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080383 is the FDA 510(k) clearance record for AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING, cleared for Convatec, A Division of E.R. Squibb & Sons, LLC on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 84 510(k) clearances for Convatec, A Division of E.R. Squibb & Sons, LLC, from to . As of , FDA records show no recalls naming K080383.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Convatec, A Division of E.R. Squibb & Sons, LLC 200 Headquarters Park Dr., Skillman NJ
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