510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K024010Substantially Equivalent

Dover Silver Hydrogel Coated Silicone Foley Catheter

The Kendall Company Div. of Tyco Healthcare Group, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024010 is the FDA 510(k) clearance record for DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER, a class II device, cleared for The Kendall Company Div. of Tyco Healthcare Group on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 4 510(k) clearances for The Kendall Company Div. of Tyco Healthcare Group, from to . As of , FDA records show one recall naming K024010.

Clearance record

Decision date
Received
(189 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Kendall Company Div. of Tyco Healthcare Group 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZL

Trailing 12 months
3 clearances under product code EZL in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260