510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901155Substantially Equivalent

Duoderm* Control Gel Formula Border Dressing

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

K901155 is the FDA 510(k) clearance record for DUODERM* CONTROL GEL FORMULA BORDER DRESSING, 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 K901155.

Clearance record

Decision date
Received
(34 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 P.O. Box 4000, Princeton 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260