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Touchless Clean-Cath

by Diamed Division Ill. Tool Works, Inc. 510(k)

Active United States Open recall

510(k) K802665

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802665 Date12 Nov 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-3117-2026 FDA Class II initiated 25 Jun 2026

    Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

    • Terminated Z-1431-2021 FDA Class II initiated 11 Jan 2021

    The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

Specification

510(k)

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

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