Kendall Curity Urethral Catheters

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

510(k) Number

K892442 ↗

FDA Product Code

GBM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Curity Venous Catheterization Kit

  Class II

  FDA 510(k) K861828 Active Cleared 10 Jul 1986

• Curity Fiberoptic Intubating Airway

  Class I

  FDA 510(k) K855137 Active Cleared 11 Mar 1986

• Curity Curad Bandages

  Class I

  FDA 510(k) K810126 Active Cleared 6 Feb 1981

• The Kendall Urinary Output Monitor

  Class I

  FDA 510(k) K852083 Active Cleared 20 Sep 1985

• Kendall Curity Irrigation Syringe

  Class II

  FDA 510(k) K892436 Active Cleared 14 Jul 1989

• Curity Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K871066 Active Cleared 15 May 1987

See all devices from The Kendal Co. →

• What medical specialties are these catheters primarily associated with and why?

  The Kendall Curity Urethral Catheters are primarily associated with the specialties of gastroenterology and urology, as indicated by their regulatory classification under product code GBM and advisory committee designation. This classification reflects their use in procedures and conditions relevant to both specialties, such as urinary drainage and certain diagnostic or therapeutic interventions involving the urinary tract.

• Are these catheters intended for single-use or can they be reused? How should they be handled?

  The data provided does not explicitly state whether the catheters are single-use or reusable. However, urethral catheters of this type are typically designed for single-use to minimize infection risks. If reuse is considered, strict adherence to manufacturer guidelines for cleaning, sterilization, and inspection would be required, though this is not specified in the provided details. Always verify with the manufacturer’s instructions for use.

• What regulatory pathway was used to clear these catheters, and when was the clearance granted?

  The Kendall Curity Urethral Catheters were cleared through the traditional 510(k) pathway by the FDA on June 23, 1989, under K-number K892442. This pathway demonstrates that the device was determined to be substantially equivalent to a predicate device already on the market, ensuring compliance with regulatory standards for safety and effectiveness.

• What sizes or models of these catheters are available, and how can I identify them?

  The provided data lists multiple FEI numbers (e.g., 1000121056, 3002806934) associated with the Kendall Curity Urethral Catheters, which likely correspond to different sizes, models, or variations of the product. These identifiers are used in regulatory filings and may align with specific French (Fr) sizes or other technical specifications. For precise sizing details, refer to the manufacturer’s packaging or product documentation, as the data does not specify exact measurements.