510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980382Substantially Equivalent for Some Indications

Non-Woven Compress

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

K980382 is the FDA 510(k) clearance record for NON-WOVEN COMPRESS, a class I device, cleared for Convatec, A Division of E.R. Squibb & Sons on under FDA product code KMF (Bandage, Liquid). FDA records list 84 510(k) clearances for Convatec, A Division of E.R. Squibb & Sons, from to . As of , FDA records show no recalls naming K980382.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Convatec, A Division of E.R. Squibb & Sons 100 Headquarters Park Dr., Skillman NJ
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