Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K140953 ↗

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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  FDA 510(k) K173675 Active Cleared 20 Jul 2018

• AQUACEL Ag Surgical SP Dressing Open recall

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  FDA 510(k) K152926 Active Cleared 21 Jan 2016

• Vitala Continence Control Device

  Class I

  FDA 510(k) K083785 Active Cleared 2 Apr 2010

• GentleCath Glide Intermittent Catheter

  Class II

  FDA 510(k) K161344 Active Cleared 20 Sep 2016

• GentleCath Glide Intermittent Urinary Catheter

  Class II

  FDA 510(k) K181206 Active Cleared 16 Aug 2018

• Duoderm Hydroactive Dressing

  Unclassified

  FDA 510(k) K973689 Active Cleared 23 Dec 1997

See all devices from Convatec, Ltd. →