510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990500Substantially Equivalent

Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C

The Kendal Co., Mansfield MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K990500 is the FDA 510(k) clearance record for KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C, a class II device, cleared for The Kendal Co. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 63 510(k) clearances for The Kendal Co., from to . As of , FDA records show one recall naming K990500.

Clearance record

Decision date
Received
(223 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 Kendal Co. 15 Hampshire St., Mansfield MA
510(k) summary
Summary
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