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Dover Silver Hydrogel Coated Silicone Foley Catheter

by The Kendall Company Div. of Tyco Healthcare Group

510(k) K024010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK024010 Date11 Jun 2003ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1050-2024 FDA Class I initiated 4 Dec 2023

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EZL
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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