Male Urinary Catheter External

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K761059 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Foley Catheters

  Class II

  FDA 510(k) K781457 Active Cleared 20 Sep 1978

• Irrigation Tray

  Class II

  FDA 510(k) K781748 Active Cleared 12 Dec 1978

• Non Sterile Parenteral Supply Kit

  Class II

  FDA 510(k) K900857 Active Cleared 22 May 1990

• ReminGel

  Class II

  FDA 510(k) K241489 Active Cleared 8 Jan 2025

• Gen. Purpose Instrument Trays &

  Class I

  FDA 510(k) K833058 Active Cleared 31 Jan 1984

• Sealer Solvent

  Unclassified

  FDA 510(k) K241354 Active Cleared 27 Aug 2024

See all devices from Intermed, Inc. →

• What is the intended use of the Intermed Male Urinary Catheter External?

  It is designed for external urinary management in male patients. As a Class II urological device, it provides a non‑invasive way to collect urine, helping clinicians maintain hygiene and monitor output without internal catheterization.

• In what sizes is the catheter offered and how is it packaged?

  The catheter is supplied in a range of sizes to accommodate different anatomies. Each size is provided as a sterile, single‑use unit, ensuring that clinicians can select the appropriate fit for each patient while avoiding cross‑contamination.

• Is the device sterile and can it be reused?

  Yes, each catheter is delivered sterile and intended for one‑time use only. Reusing the device could compromise sterility and increase infection risk, so a new sterile unit should be used for each patient encounter.

• What regulatory pathway does this catheter follow?

  The product was cleared through the FDA 510(k) process under product code KOD, indicating it is substantially equivalent to a legally marketed predicate device. This clearance confirms compliance with applicable safety and performance standards for Class II devices.