Catheter, External Male Nursing Care

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781780 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hypodermic Needles & Syringes

  Class I

  FDA 510(k) K821348 Active Cleared 10 Jun 1982

• Medi-Tech Dilatation Catheters

  Class II

  FDA 510(k) K843383 Active Cleared 24 Oct 1984

• Catheter, Transluminal Balloon

  Class I

  FDA 510(k) K781772 Active Cleared 6 Mar 1979

• Enter-A1 Enteric Feeding Tube

  Class II

  FDA 510(k) K812279 Active Cleared 25 Aug 1981

• Coagulation Reference Plasma, Abnormal

  Class II

  FDA 510(k) K904073 Active Cleared 22 Oct 1990

• Therapeutic Drug Monitoring Control, Unassayed

  Class I

  FDA 510(k) K942552 Active Cleared 9 Sep 1994

See all devices from Medi-Tech, Inc. →

• What is the Medi-Tech External Male Nursing Catheter used for?

  This device is designed as a non-invasive urinary drainage system for external male nursing care. It collects urine externally while providing a protective barrier to prevent skin exposure, reducing discomfort and irritation caused by incontinence. It is particularly suited for clinical environments like rehabilitation units, where nursing staff can apply it without requiring a physician’s order.

• Is the Medi-Tech External Male Nursing Catheter sterile and single-use?

  Yes, the device is supplied sterile and intended for single-use only. This ensures hygiene and reduces the risk of infection, making it ideal for clinical settings where contamination control is critical.

• How is the Medi-Tech External Male Nursing Catheter applied?

  The catheter is applied over the penis to divert urine into a drainage bag. It functions as a non-invasive system, meaning it does not require insertion into the urethra. The design allows nursing staff to apply it directly in clinical settings without the need for a physician’s order.

• Can this catheter be reused?

  No, the Medi-Tech External Male Nursing Catheter is explicitly designed for single-use only. Reusing it could compromise sterility and increase the risk of infection or irritation, which is why it is not intended for reuse.

• What regulatory pathway does this device follow?

  The Medi-Tech External Male Nursing Catheter follows the FDA 510(k) clearance pathway, specifically under the Gastroenterology and Urology advisory committee. It was granted clearance as substantially equivalent to a predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use.