510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780409Substantially Equivalent

Coloplast-Duraseal Ostomy Appliance

C.R. Bard Inc, Warrendale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780409 is the FDA 510(k) clearance record for COLOPLAST-DURASEAL OSTOMY APPLIANCE, a class I device, cleared for C.R. Bard, Inc. on under FDA product code EZS (Appliance, Colostomy, Disposable). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K780409.

Clearance record

Decision date
Received
(45 days to decision)
Product code
EZS Appliance, Colostomy, Disposable
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 110 Marshall Dr., Warrendale PA
Third party review
No

Clearances, product code EZS

Trailing 12 months

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

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