Assure-Male External Incontince Catheter

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

510(k) Number

K821848 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Assure-Male External Incontinence Catheter used for?

  The Assure-Male External Incontinence Catheter is designed for external urinary collection in male patients with incontinence. It functions as a collector for urine without requiring an indwelling catheter, providing an alternative management option for urinary incontinence.

• Is the Assure-Male External Incontinence Catheter single-use or reusable?

  The Assure-Male External Incontinence Catheter is supplied as a single-use product. It is designed to be used once and then discarded to maintain hygiene and prevent infection.

• What sizes are available for the Assure-Male External Incontinence Catheter?

  The device is available in various sizes as indicated by the multiple registration numbers associated with this product. The specific sizes are not detailed in the provided information, but the manufacturer offers multiple options to accommodate different patient needs.

• What is the regulatory status of the Assure-Male External Incontinence Catheter?

  The Assure-Male External Incontinence Catheter is regulated under FDA 510(k) clearance with product code KNX and is classified under regulation number 876.5250. It has been determined to be substantially equivalent to other devices in its class.