510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983519Substantially Equivalent

Comfeel Seasorb Dressing

MEDLINE INDUSTRIES, LP - Northfield, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983519 is the FDA 510(k) clearance record for COMFEEL SEASORB DRESSING, a class I device, cleared for Coloplast Corp. on under FDA product code KMF (Bandage, Liquid). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show one recall naming K983519.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Coloplast Corp. 1955 W. Oak Cir., Marietta GA
510(k) summary
Summary
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

FDA records show no clearances under product code KMF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMF, 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