510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844341Substantially Equivalent

United Skin Barrier Paste

Howmedica Corp., Ny NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844341 is the FDA 510(k) clearance record for UNITED SKIN BARRIER PASTE, a class I device, cleared for Howmedica Corp. on under FDA product code EZR (Cement, Stomal Appliance, Ostomy). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K844341.

Clearance record

Decision date
Received
(71 days to decision)
Product code
EZR Cement, Stomal Appliance, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Howmedica Corp. 235 E. 42nd St., Ny NY
Third party review
No

Clearances, product code EZR

Trailing 12 months

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

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