Rusch Brillant Silicone Foley Catheter

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

Full name

Rusch Brillant Silicone Foley

510(k) Number

K993063 ↗

FDA Product Code

EZL

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Epidural Catheter Models 1210/1200

  Class II

  FDA 510(k) K983125 Active Cleared 17 Nov 1998

• Flocath

  Class II

  FDA 510(k) K000070 Active Cleared 18 Feb 2000

• Intermittent Urethral Catheters

  Class II

  FDA 510(k) K033023 Active Cleared 23 Dec 2003

• Rusch Miller-Abbott Tube

  Class II

  FDA 510(k) K010797 Active Cleared 26 Feb 2002

• Rusch Floneil; Flocath Introgel

  Class II

  FDA 510(k) K020714 Active Cleared 1 Jul 2002

• Rusch Schroeder Endotracheal Tube Style

  Class I

  FDA 510(k) K955238 Active Cleared 6 Feb 1996

See all devices from Rusch Intl. →

• What clinical settings is the Rusch Brillant Silicone Foley Catheter primarily used in, and why is it suitable for those environments?

  The Rusch Brillant Silicone Foley Catheter is designed for clinical settings like urology and gastroenterology procedures. Its silicone shaft and integrated balloon provide secure placement within the bladder, ensuring continuous urine drainage while maintaining patency—critical for patient comfort and infection control in these specialties.

• Is the Rusch Brillant Silicone Foley Catheter reusable, and if not, how should it be disposed of after single use?

  The device is explicitly labeled as a single-use, sterile, disposable catheter. After use, it must be discarded as medical waste following local hospital or facility protocols for contaminated disposable medical devices to prevent cross-contamination.

• What storage conditions are required for the Rusch Brillant Silicone Foley Catheter, and how should it be handled before use?

  The catheter requires no special storage conditions beyond standard sterile supply protocols. It is supplied in sterile packaging, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for integrity before use to ensure sterility.

• Are there multiple sizes available for the Rusch Brillant Silicone Foley Catheter, and how would a clinician determine the appropriate size for a patient?

  Yes, the catheter is available in multiple sizes, though the exact dimensions are not specified in the provided data. Selection typically depends on patient anatomy, clinical guidelines, and practitioner discretion—commonly based on factors like patient age, gender, and medical history. Always refer to manufacturer guidelines or consult a urology specialist for size recommendations.

• What regulatory pathway was followed for FDA clearance of the Rusch Brillant Silicone Foley Catheter, and what does this mean for clinicians?

  The device received FDA 510(k) clearance (K993063) under regulation 876.5130, classified as a Class II medical device, with a substantially equivalent determination. This means it was deemed comparable to a legally marketed predicate device and meets FDA safety and effectiveness requirements. Clinicians can trust it has undergone regulatory review for its intended use in urinary drainage.